A survey on perceived medication guide reading and comprehension ease among US adults.

Medication guides (MGs) provide patients with important information about certain prescription drugs to help them take these drugs safely. We surveyed US residents about their perceptions of MG readability and understandability. We randomly sampled 5204 US residents (age 18+) from Ipsos's KnowledgePanel to complete a two-part survey. Only respondents who reported receiving an MG with their prescription drugs (n = 3852) completed part 2, which included two key items: How easy to [(1)read/(2)understand] are the MGs that you have received from a pharmacy along with your prescription medicines? (1 = Very easy, 5 = Very difficult; reverse-coded). Health literacy (HL) and demographic data were also collected. After weighting our data, we found that 85% of respondents who reported receiving an MG perceived this information as 'very easy' (27.3%), 'somewhat easy' (28.3%) or 'about average' (29.3%) to read. Eighty-seven percent of respondents who reported receiving an MG perceived it as 'very easy' (27.6%), 'somewhat easy' (30.2%) or 'about average' (29.5%) to understand. ANOVAs revealed higher average perceived MG reading and comprehension ease scores among respondents presumed to have adequate versus inadequate HL (ps ≤ 0.0006). Younger or less-educated respondents and non-Hispanic Blacks perceived MGs as easier to read and understand, on average, than their counterparts (ps ≤ 0.0001). Many of these relationships remained intact in models predicting perceived MG reading and comprehension ease (ps ≤ 0.001). Adjusted R2 values across models were small, however (≤0.06). Our findings suggest most US residents (18+) who received MGs perceived them to be 'about average' to 'very easy' to read and understand.

PROPHETIC EU: Prospective Identification of Pneumonia in Hospitalized Patients in the Intensive Care Unit in European and United States Cohorts.

Background: The prospective identification of patients at high risk for hospital-acquired/ventilator-associated bacterial pneumonia may improve clinical trial feasibility and foster antibacterial development. In a prior study conducted in the United States, clinical criteria were used to prospectively identify these patients; however, these criteria have not been applied in a European population. Methods: Adults considered high risk for pneumonia (treatment with ventilation or high levels of supplemental oxygen) in the intensive care units of 7 European hospitals were prospectively enrolled from June 12 to December 27, 2017. We estimated the proportion of high-risk patients developing pneumonia according to US Food and Drug Administration guidance and a subset potentially eligible for antibacterial trial enrollment. We compared patient characteristics, treatment exposures, and pneumonia incidence in a European cohort and a previously described US cohort. Results: Of 888 high-risk patients, 211/888 (24%) were treated for possible pneumonia, and 150/888 (17%) met the Food and Drug Administration definition for hospital-acquired/ventilator-associated bacterial pneumonia. A higher proportion of European patients treated for possible pneumonia met the pneumonia definition (150/211 [71%] vs 537/1464 [37%]; P < .001). Among patients developing pneumonia, a higher proportion of European patients met antibacterial trial eligibility criteria (124/150 [83%] vs 371/537 [69%]; P < .001). Conclusions: Clinical criteria prospectively identified high-risk patients with high rates of pneumonia in the European cohort. Despite higher rates of established risk factors and incident pneumonia, European patients were significantly less likely to receive antibiotics for possible pneumonia than US patients. Different treatment practices may contribute to lower rates of antibacterial trial enrollment in the United States.

Biennial Analysis of Medication Guide Length and Estimated Readability for New Molecular Entity Drugs, 2011-2017.

BACKGROUND: A medication guide (MG) is a form of FDA-approved labeling that provides patients with information about certain prescribed drugs so that patients can use these drugs safely and effectively. Given ongoing efforts by FDA and industry to continuously improve MG content and format, we hypothesized that more recently approved MGs for new molecular entities (NMEs) would be shorter and more readable compared to NME MGs approved earlier. METHODS: We analyzed 53 NME MGs that were either approved in 2011 (n = 16), 2013 (n = 9), 2015 (n = 12), or 2017 (n = 16) to determine whether MG page length, word count, and readability scores differed by year. Readability was estimated by Flesch Reading Ease, Flesch-Kincaid Grade Level (FKGL), Fry graph (FRY), and Gunning's Fog Index (FOG) scores. RESULTS: Mean page length was significantly lower in 2017 than in 2011 and 2013 (ps < .0001). Mean FKGL scores reflected sentences and words found in 8th grade textbooks, but mean FOG and FRY scores were consistent with sentences and words found in 10th and 11th grade textbooks. CONCLUSIONS: Although more recent NME MGs were shorter than older NME MGs, additional research is warranted to determine whether shorter MGs lead to improved readability. Developers choosing to estimate MG readability with equations should consider using multiple readability formulas and weigh the strengths and weaknesses of this approach. Using validated tools to more comprehensively assess MG readability should also be considered.

PROPHETIC: Prospective Identification of Pneumonia in Hospitalized Patients in the ICU.

BACKGROUND: Pneumonia is the leading infection-related cause of death. The use of simple clinical criteria and contemporary epidemiology to identify patients at high risk of nosocomial pneumonia should enhance prevention efforts and facilitate development of new treatments in clinical trials. RESEARCH QUESTION: What are the clinical criteria and contemporary epidemiology trends that are helpful in the identification of patients at high risk of nosocomial pneumonia? STUDY DESIGN AND METHODS: Within the ICUs of 28 US hospitals, we conducted a prospective cohort study among adults who had been hospitalized >48 hours and were considered high risk for pneumonia (defined as treatment with invasive or noninvasive ventilatory support or high levels of supplemental oxygen). We estimated the proportion of high-risk patients who experienced the development of nosocomial pneumonia. Using multivariable logistic regression, we identified patient characteristics and treatment exposures that are associated with increased risk of pneumonia development during the ICU admission. RESULTS: Between February 6, 2016, and October 7, 2016, 4,613 high-risk patients were enrolled. Among 1,464 high-risk patients (32%) who were treated for possible nosocomial pneumonia, 537 (37%) met the study pneumonia definition. Among high-risk patients, a multivariable logistic model was developed to identify key patient characteristics and treatment exposures that are associated with increased risk of nosocomial pneumonia development (c-statistic, 0.709; 95% CI, 0.686-0.731). Key factors associated with increased odds of nosocomial pneumonia included an admission diagnosis of trauma or cerebrovascular accident, receipt of enteral nutrition, documented aspiration risk, and receipt of systemic antibacterials within the preceding 90 days. INTERPRETATION: Treatment for nosocomial pneumonia is common among patients in the ICU who are receiving high levels of respiratory support, yet more than one-half of patients who are treated do not fulfill standard diagnostic criteria for pneumonia. Application of simple clinical criteria may improve the feasibility of clinical trials of pneumonia prevention and treatment by facilitating prospective identification of patients at highest risk.

Consensus on Language for Advance Informed Consent in Health Care-Associated Pneumonia Clinical Trials Using a Delphi Process.

Importance: Information to be included in advance informed consent forms for health care-associated pneumonia treatment trials remains to be determined. Objective: To identify and determine how to describe information to be included in an advance informed consent form for an early-enrollment noninferiority hospital-acquired and/or ventilator-associated bacterial pneumonia (HABP/VABP) clinical trial. Design, Setting, and Participants: A Delphi consensus process with stakeholders in HABP/VABP clinical trials was conducted using qualitative semistructured telephone interviews from June to August 2016, followed by 2 online surveys, the first from April to May 2017, and the second from September to October 2017. All stakeholders who participated in the interview were invited to participate in the first survey. Stakeholders who participated in the first survey were invited to participate in the second survey. Stakeholders were patients at risk of pneumonia, caregivers, representatives of institutional review boards, investigators, and study coordinators. Main Outcomes and Measures: Description and consensus of information to be included in advance informed consent forms for early enrollment in noninferiority HABP/VABP clinical trials. Results: Suggestions from 52 stakeholders about what key informed consent concepts to include and how to explain them were used to create 3 categories to be included in an advance consent form: (1) reassurances on patient health and treatment, (2) rationale for advance consent and early enrollment, and (3) an explanation of noninferiority. At the end of the Delphi process, at least 80% consensus was reached among the 40 stakeholders who participated in the second online survey on each of the statements to include in the proposed consent text. Throughout the process, however, describing and reaching consensus on statements about noninferiority was more problematic than the other categories. Conclusions and Relevance: The stakeholders endorsed consent language to be used in combination with a strategy for enrolling patients at highest risk for pneumonia before infection onset. Data-driven consent language may help potential participants make informed decisions about their involvement in clinical research and improve enrollment rates, which are necessary to evaluate new treatments and improve patient care. The proposed consent language may be adapted for other trials using an early enrollment strategy and for noninferiority trials.

Autosomal Dominant Frontotemporal Lobar Degeneration in a Filipino Family with Progranulin Mutation.

BACKGROUND: Compared to Western populations, familial frontotemporal lobar degeneration (FTLD) is rare among Asians. Progranulin (GRN) gene mutation, which is a major cause of FTLD, is likewise rare. We present a family with FTLD from the Philippines with an autosomal dominant pattern of inheritance and GRN mutation and briefly review reports of GRN mutations in Asia. CASE PRESENTATION: The proband is 66 years old with progressive nonfluent aphasia (PNFA)-corticobasal syndrome . We assessed 3 generations of her pedigree and found 11 affected relatives with heterogenous phenotypes, usually behavioral variant frontotemporal dementia (FTD) and PNFA. Neuroimaging showed atrophy and hypometabolism consistent with FTD syndromes. White matter hyperintensities were seen in affected members even in the absence of vascular risk factors. A GRN mutation R110X was found in 6 members, 3 with symptoms and 3 were asymptomatic. Plasma GRN was low (<112 ng/mL) in all mutation carriers. No mutations were found in microtubule-associated protein tau, APP, PSEN1, and PSEN2 genes, and all were APOE3. CONCLUSION: This is the first Filipino family with autosomal dominant FTD documented with GRN mutation. Identifying families and cohorts would contribute to therapeutic developments in an area with FTD-GRN.

Assessment of the Perceived Acceptability of an Early Enrollment Strategy Using Advance Consent in Health Care-Associated Pneumonia.

Importance: Better treatment options are needed in life-threatening infections, including health care-associated pneumonia. Enrolling patients in antibacterial clinical trials before diagnosis may circumvent existing time-to-enrollment constraints. However, the acceptability of an early enrollment strategy using advance consent is unknown. Objective: To assess the perceived acceptability of an early enrollment strategy for enrolling patients in an antibacterial clinical trial before a pneumonia diagnosis. Design, Setting, and Participants: This qualitative, descriptive study used semistructured telephone interviews. Framed within a planned noninferiority pneumonia antibiotic trial, an early enrollment strategy was described and perceptions were assessed. Using this strategy, patients give consent to enroll before developing pneumonia, to be monitored by study staff, and to be randomly assigned a study antibiotic if pneumonia develops. All interviews were audiorecorded, transcribed verbatim, and analyzed using applied thematic analysis. Fifty-two key stakeholders from across the United States, including 18 patients at risk of pneumonia, 12 caregivers, 10 representatives of institutional review boards, 7 investigators, and 5 study coordinators, were interviewed from June 20 to August 19, 2016. Main Outcomes and Measures: Perceived acceptability of the early enrollment strategy. Results: Among the 52 stakeholders interviewed (ages 29-75 years; 14 women), patients and caregivers expressed no concerns about patients being approached about participation before developing pneumonia; however, some patients may experience anxiety on learning about their risk for pneumonia. No concerns with study staff accessing patients' medical records were expressed. The clarity of consent information was important for understanding the study rather than having the condition under investigation. Among patients, caregivers, and institutional review board representatives, preferences varied regarding opt-out and precedent autonomy procedures. Nearly all patients would be willing to join a trial using the early enrollment strategy and caregivers would be willing to provide proxy consent. Institutional review board representatives were supportive of the strategy and made recommendations for the study protocol, primarily around informed consent. Investigators and study coordinators believed the strategy would not be burdensome and offered suggestions to ensure its feasibility. Conclusion and Relevance: Results of the study suggest that the early enrollment strategy is acceptable. Future research should evaluate whether the strategy improves enrollment rates in registrational pneumonia trials and in trials of other acute infection syndromes with narrow enrollment windows and/or patients with transient decisional incapacity.

Streamlining Safety Data Collection in Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Trials: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team.

BACKGROUND: Resistant bacteria are one of the leading causes of hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP). HABP/VABP trials are complex and difficult to conduct due to the large number of medical procedures, adverse events, and concomitant medications involved. Differences in the legislative frameworks between different regions of the world may also lead to excessive data collection. The Clinical Trials Transformation Initiative (CTTI) seeks to advance antibacterial drug development (ABDD) by streamlining clinical trials to improve efficiency and feasibility while maintaining ethical rigor, patient safety, information value, and scientific validity. METHODS: In 2013, CTTI engaged a multidisciplinary group of experts to discuss challenges impeding the conduct of HABP/VABP trials. Separate workstreams identified challenges associated with current data collection processes. Experts defined "data collection" as the act of capturing and reporting certain data on the case report form as opposed to recording of data as part of routine clinical care. The ABDD Project Team developed strategies for streamlining safety data collection in HABP/VABP trials using a Quality by Design approach. RESULTS: Current safety data collection processes in HABP/VABP trials often include extraneous information. More targeted strategies for safety data collection in HABP/VABP trials will rely on optimal protocol design and prespecification of which safety data are essential to satisfy regulatory reporting requirements. CONCLUSIONS: A consensus and a cultural change in clinical trial design and conduct, which involve recognition of the need for more efficient data collection, are urgently needed to advance ABDD and to improve HABP/VABP trials in particular.

Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team.

BACKGROUND: The etiology of hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP) is often multidrug-resistant infections. The evaluation of new antibacterial drugs for efficacy in this population is important, as many antibacterial drugs have demonstrated limitations when studied in this population. HABP/VABP trials are expensive and challenging to conduct due to protocol complexity and low patient enrollment, among other factors. The Clinical Trials Transformation Initiative (CTTI) seeks to advance antibacterial drug development by streamlining HABP/VABP clinical trials to improve efficiency and feasibility while maintaining ethical rigor, patient safety, information value, and scientific validity. METHODS: In 2013, CTTI engaged a multidisciplinary group of experts to discuss challenges impeding the conduct of HABP/VABP trials. Separate workstreams identified challenges associated with HABP/VABP protocol complexity. The Project Team developed potential solutions to streamline HABP/VABP trials using a Quality by Design approach. RESULTS: CTTI recommendations focus on 4 key areas to improve HABP/VABP trials: informed consent processes/practices, protocol design, choice of an institutional review board (IRB), and trial outcomes. Informed consent processes should include legally authorized representatives. Protocol design decisions should focus on eligibility criteria, prestudy antibacterial therapy considerations, use of new diagnostics, and sample size. CTTI recommends that sponsors use a central IRB and discuss trial endpoints with regulators, including defining a clinical failure and evaluating the impact of concomitant antibacterial drugs. CONCLUSIONS: Streamlining HABP/VABP trials by addressing key protocol elements can improve trial startup and patient recruitment/retention, reduce trial complexity and costs, and ensure patient safety while advancing antibacterial drug development.

Patient and physician attitudes regarding risk and benefit in streamlined development programmes for antibacterial drugs: a qualitative analysis.

OBJECTIVES: To explore patient, caregiver and physician perceptions and attitudes regarding the balance of benefit and risk in using antibacterial drugs developed through streamlined development processes. DESIGN: Semistructured focus groups and in-depth interviews were conducted to elicit perceptions and attitudes about the use of antibacterial drugs to treat multidrug-resistant infections. Participants were given background information about antibiotic resistance, streamlined drug development programmes and FDA drug approval processes. Audio recordings of focus groups/interviews were reviewed and quotes excerpted and categorised to identify key themes. PARTICIPANTS: Two primary stakeholder groups were engaged: one comprising caregivers, healthy persons and patients who had recovered from or were at risk of resistant infection (N=67; 11 focus groups); and one comprising physicians who treat resistant infections (N=23). RESULTS: Responses from focus groups/interviews indicated widespread awareness among patients/caregivers and physicians of the seriousness of the problem of antibacterial resistance. Both groups were willing to accept a degree of uncertainty regarding the balance of risk and benefit in a new therapy where a serious unmet need exists, but also expressed a desire for rigorous monitoring and rapid, transparent reporting of safety/effectiveness data. Both groups wanted to ensure that >1 physician had input on whether to treat patients with antibiotics developed through a streamlined process. Some patients/caregivers unfamiliar with exigencies of critical care suggested a relatively large multidisciplinary team, while physicians believed individual expert consultations would be preferable. Both groups agreed that careful oversight and stewardship of antibacterial drugs are needed to ensure patient safety, preserve efficacy and prevent abuse. CONCLUSIONS: Groups comprising patients/caregivers and physicians were aware of serious issues posed by resistant infections and the lack of effective antibacterial drug therapies and shared a consensus that streamlined development programmes represent a necessary response to the resistance crisis, but one that requires enhanced safeguards and risk communication.

Comparison of whole-body FDG-PET and bone scintigraphy in the evaluation of skeletal metastases in patients with breast cancer

An established standard imaging modality for detecting bone metastases in patients with breast cancer is through the use of 99mTc-hydroxymethylene diphosphonate (99mTc-IIDP) bone scintigraphy. It is clearly documented that sensitivity is generally high while specificity is often lower because of tracer uptake in non-malignant processes. The aim of this study is to evaluate the diagnostic performance of whole body 2-deoxy-2-[18F]-D- glucose positron emission tomography (18 F-FDG PET) and bone scintigraphy in the detection of bone metastasis in patients with breast cancer.METHODS: There were 232 consecutive patients who underwent FDG PET for breast cancer staging/restaging at our center during the study period. We included those who only had a bone scintigraphy within a month before or after the PET scan. The results of each image interpretation were compared retrospectively by an experienced nuclear medicine physician. Per-patient and per-lesion detection rates were collected. Bone metastasis slams was established on the basis of multimodality imaging and/or clinical follow-up for at least 6 months Weighted kappa was also calculated to determine agreement between the two modalities.RESULTS: Forty-seven patients were included in the study with ages ranging from 28-86 years. For the patient-based data, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 90%, 92.6%, 90%, 92.6%, and 91.5%, respectively, for FDG PET, and 95%, 44.4%, 55.9%, 92.3% and 66%, respectively,for bone scintigraphy. For the lesion-based data, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 66.4%, 90%, 94.7%, 50%, and 72.8%, respectively, for FDG PET, and 74.5%, 27%, 752%, 26.3% and 62.6%, respectively, for bone scintigraphy Agreement between the two modalities was slight.CONCLUSIONS: Overall, FDG PET shows to be as sensitive as bone scintigraphy in picking up bone metastases Furthermore, on both per patient and per lesion bases; PET was shown to be more confirmatory and more accurate with evidence of statistical significance. FDG PET and bone scintigraphy should play complementary roles in the detection of skeletal metastases.

Results of a Prospective Multicenter International Atomic Energy Agency Sentinel Node Trial on the Value of SPECT/CT Over Planar Imaging in Various Malignancies.

UNLABELLED: We aimed to assess the additional value of SPECT/CT over planar lymphoscintigraphy (PI) in sentinel node (SN) detection in malignancies with different lymphatic drainage such as breast cancer, melanoma, and pelvic tumors. METHODS: From 2010 to 2013, 1,508 patients were recruited in a multicenter study: 1,182 breast cancer, 262 melanoma, and 64 pelvic malignancies (prostate, cervix, penis, vulva). PI was followed by SPECT/CT 1-3 h after injection of (99m)Tc-colloid particles. Surgery was performed the same or next day. RESULTS: Significantly more SNs were detected by SPECT/CT for breast cancer (2,165 vs. 1,892), melanoma (602 vs. 532), and pelvic cancer (195 vs. 138), all P < 0.001. The drainage basin mismatch between PI and SPECT/CT was 16.5% for breast cancer, 11.1% for melanoma, and 51.6% for pelvic cancers. Surgical adjustment was 17% for breast cancer, 37% for melanoma, and 65.6% for pelvic cancer. CONCLUSION: SPECT/CT detected more SNs and changed the drainage territory, leading to surgical adjustments in a considerable number of patients in all malignancies studied but especially in the pelvic cancer group because of this group's deep lymphatic drainage. We recommend SPECT/CT in all breast cancer patients with no SN visualized on PI, all patients with melanoma of the head and neck or trunk, all patients with pelvic malignancies, and those breast cancer and melanoma patients with unexpected drainage on PI.

The first MIBG therapy in the Philippines

Neuroblastoma is an embryonal tumor of children that frequently presents with metastases. Our patient is a 6-year-old girl who was diagnosed to have neuroblastoma with diffuse metastatic disease throughout the skeleton as seen in her 123I-MIBG scan in the United States. 18F-FDG PET/CT scan was done in the Philippines after chemotherapy and gene therapy, and before 131I-MIBG therapy. No additional lesions were seen on PET.  131I-MIBG was then performed and an 131I-MIBG with SPECT/CT thereafter, which showed an increase in size and extent of the lesion in the head and a decrease in number of the skeletal metastases. New 131I-MIBG-avid posterior cervical lymph nodes were also localized through SPECT/CT. For this patient, a follow-up 123I/131I-MIBG scan would be more cost-effective in assessing response to therapy. Sectional imaging may be done to obviate the need for sedation of this young patient.

Are PET and PET/CT useful in pediatrics?

The value of PET in the evaluation of various disease states, particularly in oncology, has been well documented. Compared with its widespread application in adults, clinical use of PET in pediatrics is limited. Concerns of radiation exposure to the child, as well as lack of studies evaluating the diagnostic benefit of PET/CT in children, are a contributing factor. This study was conducted to review the usefulness of PET and PET/CT in the evaluation of pediatric patients and to identify unique FDG physiologic distribution in the sample population. All pediatric patients referred for PET scan from March 2002 - September 2010 were included in the study. The indication for referral was predominantly oncology-related (93.5%). Of the 85 patients included, PET/CT was able to detect new sites of metastases in 5 patients and help resolve equivocal CT findings in 12 patients. Of six patients presenting with seizures, PET successfully localized hypometabolic areas in the brain in all cases, as probable seizures foci. Physiologic distribution of F18-fluorodeoxyglucose (FDG)was noted in the thymus, adenoids/tonsils, laryngeal area and supraclavicular brown fat. PET/CT is useful in selective pediatric cases. Its value in effectively evaluating pediatric malignancies allows for early initiation of appropriate treatment and discourages unnecessary diagnostics and treatments for benign lesions. Physiologic uptake unique to children should be considered to avoid misinterpretations, reduce unnecessary treatments and follow-ups as well as provide an overall improvement in patient care.

Value of radiologic correlation and follow-up scintigraphy in detecting osseous metastasis in patients with non-specific bone scintigraphy lesions

Bone scintigraphy is highly sensitive in detecting bone metastasis but specificity is only about 50-60%. The aim of this study is to evaluate the value of radiologic correlation and followwup scintigraphy in detecting osseous metastasis in patients with equivocal bone scans. Bone scan results with non-specific interpretation of bone lesions from January to December 2007 were included. Results with no evidence of bone metastasis or metastatic bone disease were excluded from the study. Correlation with radiographs [X-ray, CT-scan, MRI] and follow-up bone scan within 6 months from the initial bone scan were reviewed. Of the 2322 bone scans, 435 have non-specific findings of bone lesions. From 435, only 228 patients have records of radiograph correlation and scintigraphic follow-up. Twenty two percent of the total population showed positive findings of bone metastasis in radiographs. The percentages of the non-specific findings determined to be negative from bone metastasis on correlation with X-ray, CT-scan, MRI and follow-up bone scan were 84%, 70%,73%, and 85%, respectively, whereas osseous metastasis revealed on radiologic correlation and follow-up scan were 76%, 30%,27%, and 75%, respectively. In conclusion, the finding of osseous metastasis in bone scan is increased when correlated with radiographs and scintigraphic follow-up.

Metastatic thyroid carcinoma in the kidney

Thyroid carcinoma, particularly papillary thyroid carcinoma, may present with a wide range of clinical course--from an indolent to an aggressive form of poorly differentiated thyroid carcinoma. About 10% of patients with papillary thyroid cancer develop distant metastasis to the lymph nodes, lungs, mediastinum, or bone. Several cases of unusual metastasis to the kidney have been reported previously. A rare case of renal metastasis from papillary thyroid carcinoma and the roles of PET and SPECT-CT in its detection are presented here.

Primary tumor size and the mapped sentinel node: Nuclear medicine in the management of early stage breast carcinoma

A treatment option for early stage breast cancer is nodal evaluation by axillary lymph node dissection (ALND). An alternative to ALND is sentinel lymph node (SLN) biopsy employing radionuclide SLN mapping. This study was designed to investigate the relationship between malignancy spread to the SLN and primary tumor size by reviewing the clinical profile of 20 female breast cancer patients who underwent radionuclide SLN mapping procedure, sentinel lymph node and primary tumor biopsy, as well as axillary lymph node dissection. The accuracy of radionuclide mapping in the identifying the sentinel node and determining the status of the axillary lymph nodes was reviewed. Among the mapped sentinel nodes, 15% were positive for metastatic lymphadenopathy and 85% without malignant spread. The malignant sentinel nodes had a mean size of 5.5 ± 0.87 cm and the negative sentinel nodes had a mean size of 2.95 ±2.2 cm. The SLN identified by radionuclide mapping truly represented the status of the rest of the axillary nodes for the presence or absence of metastatic lymphadenopathy. Primary tumor size is a prognostic factor for cancer spread to the sentinel node. However, the combination of primary tumor histology and tumor size may prove to be a stronger prognostic indicator malignancy spread to the sentinel lymph node.

Silent parathyroid adenoma mistakenly interpreted on FDG-PET as thyroid cancer metastasis in a patient with elevated thyroglobulin and negative I-131 whole body scan and removed by radioguided minimally invasive surgery.

Detection of recurrent and metastatic thyroid cancer remains a considerable challenge in patients presenting with rising thyroglobulin levels but with negative I-131 whole body scintigraphy. Such is the case in this patient with follicular thyroid cancer in whom subsequent FDG PET scanning showed a solitary hypermetabolic cervical lesion. With definitive management and multidisciplinary approach in mind, radioguided surgical excision came into play through the use of Tc-99m sestamibi, leading to successful removal of the lesion. Histopathology, however, revealed a parathyroid adenoma. This highlights the importance of considering differential diagnoses in apparent cases of recurrence to avoid potential pitfalls.

Parathyroid scintigraphy and gamma probe-guided surgery in the management of parathyroid carcinoma

This paper aims to present one of the rarest types of malignancies, parathyroid carcinoma. Parathyroid carcinoma is an important cause of primary hyper par athyroidism. Diagnostic evaluation of patients presenting with signs and symptoms of hyperparathyroidism consists of serum calcium and parathyroid hormone determination, parathyroid imaging using ultrasound, computed tomography, magnetic resonance imaging, or Tc-99m sestamibi scintigraphy, and histopathologic evaluation of tissues after surgical intervention. Therapeutic management of an identified parathyroid tumor is by parathyroidectomy during neck exploration or radioisotope-guided with the use of a gamma probe. The histology of a resected tumor determines if the initial surgery completes the management, or, in cases of parathyroid carcinoma, if another completion surgical intervention is to be made. This paper will present a patient who has been initially diagnosed with primary hyperparathyroidism and was referred to our nuclear medicine department for parathyroid scintigraphy. The patient underwent MIRP and rapid intraoperative PTH determination. Histopathologic report on the tissues revealed parathyroid carcinoma. The patient underwent a second surgery for definitive treatment. This paper will discuss the clinical role of nuclear medicine in the diagnosis and surgical management of parathyroid carcinoma.

Transient postischemic stunning evaluation by stress gated Tl-201 SPECT myocardial imaging: Effect on systolic left ventricular function.

BACKGROUND: Transient postischemic stunning (TIS) has been reported in images obtained (1/2) to 1 hour after stress with technetium 99m tracers but has not been investigated in images obtained shortly after stress with thallium 201. We also quantified the global extent and severity of TIS, which has not been done previously. METHODS AND RESULTS: We evaluated 82 patients with either treadmill or dobutamine stress Tl-201 myocardial perfusion imaging. Images were semiquantitatively examined with a 20-segment model. The extent and severity of myocardial ischemia and TIS were assessed by the summed difference score from the early and delayed scores of perfusion, wall motion (WM), and wall thickening (WT). The mean left ventricular ejection fraction (LVEF) was significantly lower in early images than in delayed images in patients with ischemia (P <.01), TIS by WM (P <.001), and TIS by WT (P <.001), and the LVEF difference was more significantly different as the summed difference score of perfusion, WM, or WT increased. No significant LVEF difference was seen in patients with ischemia who did not have TIS. CONCLUSIONS: In stress gated Tl-201 single photon emission computed tomography myocardial perfusion imaging, early TIS is frequently seen in patients with ischemia and is equivalently detected by WM and WT assessments. Significant exercise-induced transient left ventricular global dysfunction is associated with more severe and extensive ischemia and can be predicted by the measurement of the extent and severity of TIS from the same images.