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2.
JAMA Netw Open ; 5(1): e2144170, 2022 01 04.
Article in English | MEDLINE | ID: mdl-35044469

ABSTRACT

Importance: Despite the benefit of peptide receptor radionuclide therapy (PRRT) for patients with well-differentiated neuroendocrine tumors (WD NETs), no clinical metric to anticipate benefit from the therapy for individual patients has been previously defined. Objective: To assess whether the prognostic ability of the clinical score (CS) could be validated in an external cohort of patients with WD NETs. Design, Setting, and Participants: This multicenter cohort study's analysis included patients with WD NETs who were under consideration for peptide receptor radionuclide therapy (PRRT) with lutetium-177 (177Lu)-dotatate between March 1, 2016, and March 17, 2020. The original cohort included patients from Vanderbilt-Ingram Cancer Center. The validation cohort included patients from Ochsner Medical Center, Markey Cancer Center, and Rush Medical Center. Patients with paragangliomas, pheochromocytomas and neuroblastomas were excluded. Statistical analysis was performed from June to November 2021. Exposures: PRRT with 177Lu-dotatate or alternate therapies such as everolimus, sunitinib, or capecitabine plus temozolomide. Main Outcomes and Measures: The primary outcome was progression-free survival (PFS) and was estimated by the Kaplan-Meier method; a Cox proportional-hazards model adjusting for primary tumor site, tumor grade, and number of PRRT doses administered was used to analyze association between CS and outcomes. Results: A total of 126 patients (median age [IQR] age: 63.6 [52.9-70.7] years; 64 male individuals) were included in the validation cohort, and the combined cohort (validation and original cohorts combined) had a total of 248 patients (median [IQR] patient age: 63.3 [53.3-70.3] years; 126 male individuals). In the validation cohort, on multivariable analysis, for each 2-point increase in CS, PFS decreased significantly (hazard ratio, 2.61; 95% CI, 1.64-4.16). After finding an association of the CS with PFS in the validation cohort, the original and validation cohorts were combined into the cohort for this analysis. On multivariable analysis, for each 2-point increase in CS, PFS decreased significantly (hazard ratio, 2.52; 95% CI, 1.89-3.36). Conclusions and Relevance: Increases in CS were associated with worsening PFS in the validation cohort, validating findings from the original cohort. These findings suggest that the CS, to our knowledge, represents the first clinical metric to estimate anticipated benefit from PRRT for patients with WD NETs and may be a clinical tool for patients being considered for PRRT.


Subject(s)
Neuroendocrine Tumors/mortality , Neuroendocrine Tumors/radiotherapy , Radioisotopes/therapeutic use , Receptors, Peptide/therapeutic use , Severity of Illness Index , Aged , Cohort Studies , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Octreotide/analogs & derivatives , Octreotide/therapeutic use , Organometallic Compounds/therapeutic use , Predictive Value of Tests , Prognosis , Progression-Free Survival , Proportional Hazards Models , Prospective Studies , Radionuclide Imaging , Treatment Outcome
3.
Endocr Relat Cancer ; 28(3): 203-212, 2021 03.
Article in English | MEDLINE | ID: mdl-33608484

ABSTRACT

We developed a clinical score (CS) at Vanderbilt Ingram Cancer Center (VICC) that we hoped would predict outcomes for patients with progressive well-differentiated neuroendocrine tumors (NETs) receiving therapy with Lutetium-177 (177Lu)-DOTATATE. Patients under consideration for 177Lu-DOTATATE between March 1, 2016 and March 17, 2020 at VICC were assigned a CS prospectively. The CS included 5 categories: available treatments for tumor type outside of 177Lu-DOTATATE, prior systemic treatments, patient symptoms, tumor burden in critical organs and presence of peritoneal carcinomatosis. The primary outcome of the analysis was progression-free survival (PFS). To evaluate the effect of the CS on PFS, a multivariable Cox regression analysis was performed adjusting for tumor grade, primary tumor location, and the interaction between 177Lu-DOTATATE doses received (zero, 1-2, 3-4) and CS. A total of 91 patients and 31 patients received 3-4 doses and zero doses of 177Lu-DOTATATE, respectively. On multivariable analysis, in patients treated with 3-4 doses of 177Lu-DOTATATE, for each 1-point increase in CS, the estimated hazard ratio (HR) for PFS was 2.0 (95% CI 1.61-2.48). On multivariable analysis, in patients who received zero doses of 177Lu-DOTATATE, for each 1-point increase in CS, the estimated HR for PFS was 1.22 (95% CI 0.91-1.65). Among patients treated with 3-4 doses of 177Lu-DOTATATE, those with lower CS experienced improved PFS with the treatment compared to patients with higher CS. This PFS difference, based upon CS, was not observed in patients who did not receive 177Lu-DOTATATE, suggesting the predictive utility of the score.


Subject(s)
Neuroendocrine Tumors , Organometallic Compounds , Humans , Lutetium/therapeutic use , Neuroendocrine Tumors/radiotherapy , Octreotide/therapeutic use , Organometallic Compounds/therapeutic use , Positron-Emission Tomography , Radioisotopes , Radionuclide Imaging
4.
Clin Nucl Med ; 44(11): 851-854, 2019 Nov.
Article in English | MEDLINE | ID: mdl-31524686

ABSTRACT

PURPOSE: To measure the SUVs in the tail of the pancreas compared with normal liver parenchyma and somatostatin receptor-positive lesions. MATERIALS AND METHODS: Ga-DOTATATE PET/low mAs CT of 35 patients were reviewed. RESULTS: There was no significant difference (P = 0.59) between the SUVaverage of normal liver and the SUVpeak of normal tail. Five patients had uptake in the tail slightly above that of normal liver that were interpreted equivocally. In one of these patients with Ga-DOTATATE uptake in a peripancreatic lymph node, proven neuroendocrine tumor underwent a distal pancreatectomy and pathologic examination revealed islet cell hyperplasia. CONCLUSIONS: Ga-DOTATATE uptake in the tail of the pancreas above that of normal liver indicates a somatostatin receptor-avid lesion. Uptake in the tail of the pancreas equal to the liver can be normal. Patients with uptake equivalent to the liver should undergo further anatomical imaging before procedural intervention.


Subject(s)
Organometallic Compounds/metabolism , Pancreas/metabolism , Adult , Aged , Aged, 80 and over , Biological Transport , Female , Humans , Liver/diagnostic imaging , Liver/metabolism , Male , Middle Aged , Neuroendocrine Tumors/diagnostic imaging , Neuroendocrine Tumors/metabolism , Neuroendocrine Tumors/pathology , Pancreas/diagnostic imaging , Positron Emission Tomography Computed Tomography , Receptors, Somatostatin/metabolism
7.
Eur J Nucl Med Mol Imaging ; 44(8): 1269-1274, 2017 Aug.
Article in English | MEDLINE | ID: mdl-28364161

ABSTRACT

PURPOSE: To compare FDG PET/CT and CT for the guidance of percutaneous biopsies with histological confirmation of lesions. METHODS: We prospectively evaluated 323 patients of whom 181 underwent FDG PET/CT-guided biopsy (total 188 biopsies) and 142 underwent CT-guided biopsy (total 146 biopsies). Biopsies were performed using the same PET/CT scanner with a fluoroscopic imaging system. Technical feasibility, clinical success and complication rates in the two groups were evaluated. RESULTS: Of the 188 biopsies with PET/CT guidance, 182 (96.8%) were successful with conclusive tissue samples obtained and of the 146 biopsies with CT guidance, 137 (93.8%) were successful. Therefore, 6 of 188 biopsies (3.1%) with PET/CT guidance and 9 of 146 (6.1%) with CT guidance were inconclusive (p = 0.19). Due to inconclusive histological results, 4 of the 188 lesions (2.1%) were rebiopsied with PET/CT guidance and 3 of 146 lesions (2.0%) were rebiopsied with CT guidance. Histology demonstrated that 142 of 188 lesions (75.5%) were malignant, and 40 (21.2%) were benign in the PET/CT-guided group, while 89 of 146 lesions (60.9%) were malignant and 48 (32.8%) were benign in the CT-guided group (p = 0.004 and 0.01, respectively). Patients with a histological diagnosis of benign lesion had no recurrence of disease with a minimum of 6 months follow-up. Of the 188 PET/CT-guided biopsies, 6 (3.1%) were repeat biopsies due to a previous nondiagnostic CT-guided biopsy performed in a different diagnostic centre. The interval between the two biopsies was less than a month in all cases. Histology revealed five malignant lesions and one benign lesion among these. The complication rate in the PET/CT-guided biopsy group was 12.7% (24 of 188), while in the CT-guided group, was 9.5% (14 of 146, p = 0.26). Therefore, there was no significant difference in complication rates between PET/CT and CT guidance. CONCLUSION: PET/CT-guided biopsy is already known to be a feasible and accurate method in the diagnostic work-up of suspected malignant lesions. This prospective analysis of a large number of patients demonstrated the feasibility and advantages of using PET/CT as the imaging method of choice for biopsy guidance, especially where FDG-avid foci do not show corresponding lesions on the CT scan. There were no significant differences in the ability to obtain a diagnostic specimen or in the complication rates between PET/CT and CT guidance.


Subject(s)
Image-Guided Biopsy/methods , Neoplasms/diagnostic imaging , Neoplasms/pathology , Positron Emission Tomography Computed Tomography , Aged , Biological Transport , Feasibility Studies , Female , Fluorodeoxyglucose F18/metabolism , Humans , Male , Middle Aged , Neoplasms/metabolism
8.
Clin Nucl Med ; 42(5): 371-372, 2017 May.
Article in English | MEDLINE | ID: mdl-28221192

ABSTRACT

A 39-year-old man presented with new onset of sinus congestion, shortness of breath, and diaphoresis. His laboratory tests were notable for hypercalcemia and lactic acidosis. A CT scan of the head demonstrated mild paranasal disease. CT scan of the chest, abdomen, and pelvis demonstrated omental caking with lymphadenopathy and a thickened loop of bowel in the left upper quadrant suggestive of lymphoma. All abdominal lesions seen in the CT were intensely F-FDG avid with diffuse uptake in the bone marrow. There was markedly decreased F-FDG uptake in both the brain and liver. Histopathology was positive for Burkitt lymphoma.


Subject(s)
Acidosis, Lactic/diagnostic imaging , Burkitt Lymphoma/diagnostic imaging , Adult , Fluorodeoxyglucose F18 , Humans , Male , Pelvis/diagnostic imaging , Positron-Emission Tomography , Radiopharmaceuticals , Tomography, X-Ray Computed
9.
J Nucl Med ; 57(12): 20A, 2016 12.
Article in English | MEDLINE | ID: mdl-27909185
11.
J Nucl Med ; 57(6): 872-8, 2016 Jun.
Article in English | MEDLINE | ID: mdl-26769864

ABSTRACT

UNLABELLED: Neuroendocrine tumors (NETs) are uncommon tumors with increasing incidence and prevalence. Current reports suggest that (68)Ga-DOTATATE PET/CT imaging improves diagnosis and staging of NETs compared with (111)In-DTPA-octreotide and conventional imaging. We performed a systematic review of (68)Ga-DOTATATE for safety and efficacy compared with octreotide and conventional imaging to determine whether available evidence supports U.S. Food and Drug Administration approval. METHODS: Medline, EMBASE, Web of Science, and Cochrane Reviews electronic databases were searched from January 1999 to September 2015. Results were restricted to human studies comparing diagnostic accuracy of (68)Ga-DOTATATE with octreotide or conventional imaging for pulmonary or gastroenteropancreatic NET and for human studies reporting safety/toxicity for (68)Ga-DOTATATE with 10 subjects or more thought to have NETs. Direct communication with corresponding authors was attempted to obtain missing information. Abstracts meeting eligibility criteria were collected by a research librarian and assembled for reviewers; 2 reviewers independently determined whether or not to include each abstract. If either reviewer chose inclusion, the abstract was accepted for review. RESULTS: Database and bibliography searches yielded 2,479 articles, of which 42 were eligible. Three studies compared the 2 radiopharmaceuticals in the same patient, finding (68)Ga-DOTATATE to be more sensitive than octreotide. Nine studies compared (68)Ga-DOTATATE with conventional imaging. (68)Ga-DOTATATE estimated sensitivity, 90.9% (95% confidence interval, 81.4%-96.4%), and specificity, 90.6% (95% confidence interval, 77.8%-96.1%), were high. Five studies were retained for safety reporting only. Report of harm possibly related to (68)Ga-DOTATATE was rare (6 of 974), and no study reported major toxicity or safety issues. CONCLUSION: No direct comparison of octreotide and (68)Ga-DOTATATE imaging for diagnosis and staging in an unbiased population of NETs has been published. Available information in the peer-reviewed literature regarding diagnostic efficacy and safety supports the use of (68)Ga-DOTATATE for imaging of NETs where it is available.


Subject(s)
Intestinal Neoplasms/diagnostic imaging , Lung Neoplasms/diagnostic imaging , Neuroendocrine Tumors/diagnostic imaging , Octreotide/analogs & derivatives , Organometallic Compounds , Pancreatic Neoplasms/diagnostic imaging , Pentetic Acid/chemistry , Positron Emission Tomography Computed Tomography/methods , Stomach Neoplasms/diagnostic imaging , Humans , Octreotide/chemistry
12.
J Nucl Med ; 57(5): 708-14, 2016 05.
Article in English | MEDLINE | ID: mdl-26769865

ABSTRACT

UNLABELLED: Our purpose was to evaluate the safety and efficacy of (68)Ga-DOTATATE PET/CT compared with (111)In-pentetreotide imaging for diagnosis, staging, and restaging of pulmonary and gastroenteropancreatic neuroendocrine tumors. METHODS: (68)Ga-DOTATATE PET/CT and (111)In-pentetreotide scans were obtained for 78 of 97 consecutively enrolled patients with known or suspected pulmonary or gastroenteropancreatic neuroendocrine tumors. Safety and toxicity were measured by comparing vital signs, serum chemistry values, or acquisition-related medical complications before and after (68)Ga-DOTATATE injection. Added value was determined by changes in treatment plan when (68)Ga-DOTATATE PET/CT results were added to all prior imaging, including (111)In-pentetreotide. Interobserver reproducibility of (68)Ga-DOTATATE PET/CT scan interpretation was measured between blinded and nonblinded interpreters. RESULTS: (68)Ga-DOTATATE PET/CT and (111)In-pentetreotide scans were significantly different in impact on treatment (P < 0.001). (68)Ga-DOTATATE PET/CT combined with CT or liver MRI changed care in 28 of 78 (36%) patients. Interobserver agreement between blinded and nonblinded interpreters was high. No participant had a trial-related event requiring treatment. Mild, transient events were tachycardia in 1, alanine transaminase elevation in 1, and hyperglycemia in 2 participants. No clinically significant arrhythmias occurred. (68)Ga-DOTATATE PET/CT correctly identified 3 patients for peptide-receptor radiotherapy incorrectly classified by (111)In-pentetreotide. CONCLUSION: (68)Ga-DOTATATE PET/CT was equivalent or superior to (111)In-pentetreotide imaging in all 78 patients. No adverse events requiring treatment were observed. (68)Ga-DOTATATE PET/CT changed treatment in 36% of participants. Given the lack of significant toxicity, lower radiation exposure, and improved accuracy compared with (111)In-pentetreotide, (68)Ga-DOTATATE imaging should be used instead of (111)In-pentetreotide imaging where available.


Subject(s)
Intestinal Neoplasms/diagnostic imaging , Intestinal Neoplasms/therapy , Lung Neoplasms/diagnostic imaging , Lung Neoplasms/therapy , Neuroendocrine Tumors/diagnostic imaging , Neuroendocrine Tumors/therapy , Organometallic Compounds/adverse effects , Pancreatic Neoplasms/diagnostic imaging , Pancreatic Neoplasms/therapy , Positron Emission Tomography Computed Tomography/adverse effects , Safety , Stomach Neoplasms/diagnostic imaging , Stomach Neoplasms/therapy , Female , Humans , Indium Radioisotopes , Intestinal Neoplasms/pathology , Lung Neoplasms/pathology , Male , Middle Aged , Neoplasm Staging , Neuroendocrine Tumors/pathology , Observer Variation , Pancreatic Neoplasms/pathology , Somatostatin/adverse effects , Somatostatin/analogs & derivatives , Stomach Neoplasms/pathology
13.
J Nucl Med ; 56(9): 1391-4, 2015 Sep.
Article in English | MEDLINE | ID: mdl-26205299

ABSTRACT

UNLABELLED: The 2010 North American Consensus Guidelines (NACG) for pediatric administered doses and the European Association of Nuclear Medicine (EANM) Dosage Card guidelines recommend lower activities than those administered at our institution. We compared the quality of the lower-activity images with the higher-activity images to determine whether the reduction in counts affects overall image quality. METHODS: Twenty patients presenting to our pediatric radiology department for bone scintigraphy were evaluated. Their mean weight was 20 kg. The patients were referred for oncologic (n = 10), infectious/inflammatory (n = 5), and pain (n = 5) evaluation. Dynamic anterior and posterior images were acquired for 5 min for each patient. Data were subsampled to represent different administered activities corresponding to the activities recommended by the NACG and the EANM Dosage Card. Images were evaluated twice, first for diagnostic quality and then for acceptability for daily clinical use. RESULTS: There was no statistically significant difference in the diagnostic quality of the images from any of the 3 protocols. Pathologic uptake was correctly identified independent of the administered activity, although there was a single false-positive result for an EANM image. When images were subjectively evaluated as acceptable for daily clinical use, there was a slight preference for the higher-activity images over the NACG (P = 0.04). CONCLUSION: The recommended administered activities of the NACG produce images of diagnostic quality while reducing patient radiation exposure.


Subject(s)
Bone Diseases/diagnostic imaging , Fluorodeoxyglucose F18/administration & dosage , Medical Oncology/standards , Pediatrics/standards , Positron-Emission Tomography/standards , Adolescent , Child , Child, Preschool , Female , Guideline Adherence , Humans , Image Enhancement/standards , Infant , Male , North America , Practice Guidelines as Topic , Radiation Dosage , Radiation Protection/standards , Radiopharmaceuticals/administration & dosage , Reproducibility of Results , Sensitivity and Specificity , Tennessee
17.
Eur J Nucl Med Mol Imaging ; 42(2): 328-54, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25452219

ABSTRACT

The purpose of these guidelines is to assist physicians in recommending, performing, interpreting and reporting the results of FDG PET/CT for oncological imaging of adult patients. PET is a quantitative imaging technique and therefore requires a common quality control (QC)/quality assurance (QA) procedure to maintain the accuracy and precision of quantitation. Repeatability and reproducibility are two essential requirements for any quantitative measurement and/or imaging biomarker. Repeatability relates to the uncertainty in obtaining the same result in the same patient when he or she is examined more than once on the same system. However, imaging biomarkers should also have adequate reproducibility, i.e. the ability to yield the same result in the same patient when that patient is examined on different systems and at different imaging sites. Adequate repeatability and reproducibility are essential for the clinical management of patients and the use of FDG PET/CT within multicentre trials. A common standardised imaging procedure will help promote the appropriate use of FDG PET/CT imaging and increase the value of publications and, therefore, their contribution to evidence-based medicine. Moreover, consistency in numerical values between platforms and institutes that acquire the data will potentially enhance the role of semiquantitative and quantitative image interpretation. Precision and accuracy are additionally important as FDG PET/CT is used to evaluate tumour response as well as for diagnosis, prognosis and staging. Therefore both the previous and these new guidelines specifically aim to achieve standardised uptake value harmonisation in multicentre settings.


Subject(s)
Fluorodeoxyglucose F18 , Multimodal Imaging/methods , Neoplasms/diagnostic imaging , Positron-Emission Tomography/methods , Radiopharmaceuticals , Tomography, X-Ray Computed/methods , Humans
19.
J Nucl Med ; 55(3): 22A, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24591562
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