The management of emergency spinal surgery during the COVID-19 pandemic in Italy.

AIMS: The current pandemic caused by COVID-19 is the biggest challenge for national health systems for a century. While most medical resources are allocated to treat COVID-19 patients, several non-COVID-19 medical emergencies still need to be treated, including vertebral fractures and spinal cord compression. The aim of this paper is to report the early experience and an organizational protocol for emergency spinal surgery currently being used in a large metropolitan area by an integrated team of orthopaedic surgeons and neurosurgeons. METHODS: An organizational model is presented based on case centralization in hub hospitals and early management of surgical cases to reduce hospital stay. Data from all the patients admitted for emergency spinal surgery from the beginning of the outbreak were prospectively collected and compared to data from patients admitted for the same reason in the same time span in the previous year, and treated by the same integrated team. RESULTS: A total of 19 patients (11 males and eight females, with a mean age of 49.9 years (14 to 83)) were admitted either for vertebral fracture or spinal cord compression in a 19-day period, compared to the ten admitted in the previous year. No COVID-19 patients were treated. The mean time between admission and surgery was 1.7 days, significantly lower than 6.8 days the previous year (p < 0.001). CONCLUSION: The structural organization and the management protocol we describe allowed us to reduce the time to surgery and ultimately hospital stay, thereby maximizing the already stretched medical resources available. We hope that our early experience can be of value to the medical communities that will soon be in the same emergency situation. Cite this article: Bone Joint J 2020;102-B(6):671-676.

A rare case of cervical junction ligamentous cyst.

Ligamentous cyst is a cystic formation arising from degeneration of ligamentous structures all around the spinal cord. They can cause spinal cord compression, like synovial cyst. Unlike synovial cyst, there is no spinal instability in pathogenesis of ligamentous cyst. Differential diagnosis through pre-operative MRI is difficult and intraoperative findings plus histopathology are crucial to achieve a diagnosis. In this case report, we deal with a rare case of cervical junction ligamentous cyst. A 59-year-old Caucasian female was admitted in our ward with left-sided hemiparesis, cervical pain, and upper limb diffused paresthesias, due to an oval-shaped formation into ALL, of 13 mm in maximum diameter, with peripheral contrast enhancement. The patient underwent, under general anesthesia, a surgery through a posterolateral suboccipital approach which aimed to decompress the spinal cord and to drain the cyst with total removal of the compression by emptying the cyst and fulfilling it with muscle graft and glue. No posterior fixation was needed. After the surgery, symptoms improved and a post-operative MRI scan demonstrated the good result of the surgery.

Radioembolization of hepatocarcinoma with (90)Y glass microspheres: development of an individualized treatment planning strategy based on dosimetry and radiobiology.

PURPOSE: The aim of this study was to optimize the dosimetric approach and to review the absorbed doses delivered, taking into account radiobiology, in order to identify the optimal methodology for an individualized treatment planning strategy based on (99m)Tc-macroaggregated albumin (MAA) single photon emission computed tomography (SPECT) images. METHODS: We performed retrospective dosimetry of the standard TheraSphere® treatment on 52 intermediate (n = 17) and advanced (i.e. portal vein thrombosis, n = 35) hepatocarcinoma patients with tumour burden < 50% and without obstruction of the main portal vein trunk. Response was monitored with the densitometric radiological criterion (European Association for the Study of the Liver) and treatment-related liver decompensation was defined ad hoc with a time cut-off of 6 months. Adverse events clearly attributable to disease progression or other causes were not attributed to treatment. Voxel dosimetry was performed with the local deposition method on (99m)Tc-MAA SPECT images. The reconstruction protocol was optimized. Concordance of (99m)Tc-MAA and (90)Y bremsstrahlung microsphere biodistributions was studied in 35 sequential patients. Two segmentation methods were used, based on SPECT alone (home-made code) or on coregistered SPECT/CT images (IMALYTICS™ by Philips). STRATOS™ absorbed dose calculation was validated for (90)Y with a single time point. Radiobiology was used introducing other dosimetric variables besides the mean absorbed dose D: equivalent uniform dose (EUD), biologically effective dose averaged over voxel values (BEDave) and equivalent uniform biologically effective dose (EUBED). Two sets of radiobiological parameters, the first derived from microsphere irradiation and the second from external beam radiotherapy (EBRT), were used. A total of 16 possible methodologies were compared. Tumour control probability (TCP) and normal tissue complication probability (NTCP) were derived. The area under the curve (AUC) of the receiver-operating characteristic (ROC) curve was used as a figure of merit to identify the methodology which gave the best separation in terms of dosimetry between responding and non-responding lesions and liver decompensated vs non-decompensated liver treatment. RESULTS: MAA and (90)Y biodistributions were not different (71% of cases), different in 23% and uncertain in 6%. Response correlated with absorbed dose (Spearman's r from 0.48 to 0.69). Responding vs non-responding lesion absorbed doses were well separated, regardless of the methodology adopted (p = 0.0001, AUC from 0.75 to 0.87). EUBED gave significantly better separation with respect to mean dose (AUC = 0.87 vs 0.80, z = 2.07). Segmentation on SPECT gave better separation than on SPECT/CT. TCP(50%) was at 250 Gy for small lesion volumes (<10 cc) and higher than 1,000 Gy for large lesions (>10 cc). Apparent radiosensitivity values from TCP were around 0.003/Gy, a factor of 3-5 lower than in EBRT, as found by other authors. The dose-rate effect was negligible: a purely linear model can be applied. Toxicity incidence was significantly larger for Child B7 patients (89 vs 14%, p < 0.0001), who were therefore excluded from dose-toxicity analysis. Child A toxic vs non-toxic treatments were significantly separated in terms of dose averaged on whole non-tumoural parenchyma (including non-irradiated regions) with AUC from 0.73 to 0.94. TD50 was ≈ 100 Gy. No methodology was superior to parenchyma mean dose, which therefore can be used for planning, with a limit of TD15 ≈ 75 Gy. CONCLUSION: A dosimetric treatment planning criterion for Child A patients without complete obstruction of the portal vein was developed.

Acute traumatic fractures to the craniovertebral junction: preliminary experience with the "MILD" score scale.

PURPOSE: Traumatic fractures to the craniovertebral junction (CVJ) are rare events requiring complex clinical management. Several classification systems are currently in use; however, recent improvements of junctional knowledge has focused attention on the role of ligaments and membranes in vertebral biomechanical stability. The aim of this study was to present our preliminary experience with the "MILD" score scale, which should allow fast and effective classification of all CVJ traumatic fractures based on vertebral instability in the acute setting. METHODS: A prospective study was conducted on 38 consecutive patients with 43 traumatic junctional fractures identified by computed tomography (CT) scan in the acute trauma phase. The MILD scale was applied to all fractures, and a score was obtained for each patient. All cases underwent magnetic resonance imaging (MRI) to assess the anatomical integrity of ligaments and membranes. RESULTS: Twenty-seven patients (71 %) were classified as MILD type 1 (0-1 points), showed a negative MRI, and healed with conservative treatment. Eight patients (21 %) were classified as MILD type 2 (2 points) and showed modest indirect signs of ligamentous injuries. Four of these patients healed with conservative treatment, while three patients underwent surgery due to wide bone fracture fragment displacement. Three patients (8 %) were classified as MILD type 3 (3 points), all of whom showed extensive ligamentous damage and underwent surgery. CONCLUSIONS: The close association between the MILD scale and spinal instability is promising, although further studies are warranted in order to confirm our preliminary data.

Iodine-131 metaiodobenzylguanidine (I-131 MIBG) diagnosis and therapy of pheochromocytoma and paraganglioma: current problems, critical issues and presentation of a sample case.

Iodine-131 metaiodobenzylguanidine (I-131 MIBG) has been used for the diagnosis and treatment of malignant pheochromocytomas (PHEO) and paragangliomas (PGL) since 1980's. Despite increasing amount of experience with iodine-131 (I-131) MIBG therapy, many important questions still exist. In this article, we will discuss the current problems learned from clinical experience in diagnosis and therapy of PHEO/PGL with I-131 MIBG, and present a sample case to emphasize the critical aspects for an optimal treatment strategy.

Anterior approach to the spine. Role of the general surgeon, techniques and surgical complications. The 10-year experience of the Niguarda Hospitals.

AIM: The aim of the study was to present the incidence of early and late surgical complications in a group of patients treated with anterior approach for spine lesions. The study was also focused on technical aspects for lesions of D1-D2 and L5-S1 segments and results on a group of patients underwent adjunctive surgical procedures at the same time of spinal surgery. METHODS: This was a retrospective study based on our database from April 1998 to December 2008. The study enrolled 120 consecutive patients (M/F 73/47; mean age 43.1 years; range 15-70 years) who underwent spinal surgery for trauma (92 patients), primitive or metastatic cancer (12 patients), benign lesion (2 patients), degenerative disc disease (6 patients) and infection disease (8 patients). This work describes the anterior approach to the spine. RESULTS: No death was recorded. Thirty-two patients (26.6%) presented postoperative complications: persistent urinary tract infections in 19 (15.9%), pneumonia in 6 (5%), pleural effusion in 3 (2.5%), wound infection in 2 (1.6%), retro-peritoneal abscess in 1 (0.8%) and haemorrhage in 1 (0.8%). During the follow-up (mean 3.8 years; range 2 months-10 years) 1 patient (0.8%) required two further surgical procedures for tuberculosis abscess recurrences. CONCLUSION: Anterior approach to the spine is effective and safe. Surgical complications do not negatively affect patient survival and spine stabilization included patients with D1-D2 and L5-S1 lesion and patients who receive adjunctive surgery at the same time of spine procedure.

Hypercalcaemia in systemic lupus erythematosus.

Hypercalcaemia is found in more than 90% of the cases of primitive hyperparathyroidism and malignancies. Rarely, D hypervitaminosis, sarcoidosis, other granulomatous diseases, some drugs, and endocrine diseases may be responsible. Nine patients with systemic lupus erythematosus (SLE) and hypercalcaemia, without evidence of primary hyperparathyroidism, have been previously described. Here we report the 10th patient with SLE and hypercalcaemia, along with a brief review of the literature.

Treatment with tandem [(90)Y]DOTA-TATE and [(177)Lu] DOTA-TATE of neuroendocrine tumors refractory to conventional therapy: preliminary results.

AIM: Neuroendocrine tumors over-express somatostatin receptors and literature data have demonstrated the efficacy of the peptide receptor radionuclide therapy with somatostatin analogues labelled with high activities of b-emitting radioisotopes, such as (90)Y and (177)Lu. Yttrium-90 is a pure high energy b-emitter while (177)Lu is a b/g emitter of medium energy. We decided to evaluate an original tandem treatment based on administration of radiolabeled [DOTA(0),Tyr(3)]octreotate (DOTA-TATE) alternating (177)Lu and 90Y. Aim of this study was to evaluate the feasibility, the efficacy and the toxicity of this treatment in neuroendocrine tumors expressing somatostatin receptors relapsed or refractory to conventional therapies. METHODS: Patients were treated with four therapeutic cycles alternating [(177)Lu]DOTA-TATE (5.55 GBq) and [(90)Y]DOTA-TATE (2.6 GBq). Dosimetric evaluation after administration of [(177)Lu]DOTA-TATE allows to calculate the absorbed doses in healthy organs. Blood samples were collected at 5 min, 1, 6, 24, 48, 72, 96 h and scintigraphy was performed once a day for four days after administration. Toxicity was evaluated considering hematological parameters and renal toxicity was evaluated also by the glomerular filtration rate (GFR). Efficacy related with RECIST criteria. RESULTS: Up to now 26 patients entered the study and 16 patients completed all cycles. Treatment was well tolerated with no adverse event registered. No damage to healthy organs was revealed in accordance with the calculated absorbed doses. We had a partial response in 10/15 patients evaluated three months after the fourth treatment. CONCLUSIONS: Up to now only a few patients participated in and concluded this study; preliminary results are encouraging and indicate the feasibility of the study.

(131)I-MIBG treatment of pheochromocytoma: low versus intermediate activity regimens of therapy.

AIM: Since the second half of the 1980s, (131)I-MIBG has been widely used for treatment of patients with malignant pheochromocytoma. In 1991, at the International Meeting in Rome, it was agreed that (131)I-MIBG therapy induces significant tumor responses in about 30-50% of cases, long-term stabilization of disease in several cases and significant reduction of cathecolamine-related symptoms in almost all patients. Nevertheless, more than 20 years later, its therapeutic use in malignant phaeochromocytoma has not yet been standardized. Aim of the present study was to compare the use of low versus intermediate activity of MIBG to achieve better results in a shorter time with higher activities. METHODS: Two different modalities of (131)I-MIBG therapy were performed: before 2001, 12 patients (Group 1) received a fixed activity of 5.55 GBq/session. From 2001 to 2009, 16 patients (Group 2) were treated with 9.25-12.95 GBq/session. RESULTS: As expected, the overall response rate in Group 2 are slightly better. The most important result of increasing the single session activity was the shorter median time to achieve a significant response (7 versus 19 months), which was obtained with a lower median cumulative activity (11 versus 22 GBq) in a lower median number of sessions (2 versus 7). CONCLUSIONS: We demonstrated that intermediate single session activity shortened to one third the global treatment time, with similar efficacy and a moderate increment of toxicity. Consequently, the increase of (131)I-MIBG activity, without reaching myeloablative levels, can be recommended for standard treatment of pheochromocytoma and paraganglioma patients.

A new predictive index for vertebral fractures: the sum of the anterior vertebral body heights.

UNLABELLED: Evaluation of osteoporotic vertebral fracture risk is currently based on measurement of bone mineral density (BMD), but bone strength depends also on bone quality parameters. Aim of this study was to evaluate the validity of a new vertebral morphometric index, the Anterior Vertebral Heights sum (AHs) in discriminating women at high risk of vertebral fracture, comparing its diagnostic accuracy with that of BMD measured at lumbar spine (LS-BMD) and femoral neck (FN-BMD). MATERIALS AND METHODS: A total of 163 Caucasian post-menopausal women (age range 46-74 years, mean age+/-SD=63.8+/-7.1 years), who did not present prevalent fractures at baseline evaluation, were observed at longitudinal follow-up. X-ray of the thoracic and lumbar spine, LS-BMD and FN-BMD measurements were obtained in all patients at baseline and repeated at the second follow-up visit 18-24 months later (mean 21+/-1.7 months). Radiographs of spine were analysed in order to identify vertebral fractures using a visual semiquantitative method (SQ) and vertebral morphometry as well as by calculating the AHs morphometric index. RESULTS: During follow-up, 21/163 patients (12.9%) sustained a new vertebral fracture; 95.2% (20/21) of fractured patients but only 4.9% (7/142) of non-fractured women had reduced AHs values. As regarding BMD, 66.6% (14/21) and 61.9% (13/21) of women with incident fracture were osteoporotic at lumbar spine and femoral neck baseline evaluation , whereas among non-fractured women, 38% (54/142) at LS-BMD and 33.1% (47/142) at FN-BMD were osteoporotic . Analyses of Receiver Operating Characteristic (ROC) curves showed that AHs discriminated vertebral fractures almost perfectly (AUC 0.97; 95% CI 0.95-0.99). On the other hand, the AUC for LS-BMD was only 0.73 (95% CI 0.64-0.81) and for FN-BMD was 0.72 (95%CI 0.63-0.80), showing that the diagnostic accuracy of AHs was significantly higher compared to that of LS-BMD (p<0.001) or FN-BMD (p<0.001). A modified Poisson regression model for binary data was used to assess the independent role of AHs in predicting vertebral fracture. The effect of AHs remained statistically significant (p<0.001) after adjusting by FN-BMD, age, weight and body height. CONCLUSIONS: Results of this study indicate the validity of this new morphometric index in evaluating the risk of osteoporotic vertebral fractures thus suggesting that AHs should be considered a valid parameter in clinical practice to assess the need for primary prevention of vertebral fractures.

A practical dead time correction method in planar activity quantification for dosimetry during radionuclide therapy.

AIM: Gamma camera saturation is the first quantification problem in dosimetric studies following therapeutic administrations of 131I labeled radiopharmaceuticals. A new approach for dead time correction (DTC) is here proposed. It employs planar whole-body (WB) images without the need of standard radionuclide sources or of preliminary phantom calibrations. METHODS: Step and shoot WB acquisitions of the patient are required. A program was developed to compensate for the image discontinuities ("Continuity DTC method") between two adjacent static fields of view (FOVs) caused by different dead time count losses. For its validation, authors used two 99mTc 6 GBq phantom scans after administration of six patients with 131I labeled agents with different statistics and ten clinical scans taken between 16 h and 48 h after administration of 131I labeled agents, whose activity ranged from 4 to 10 GBq. The deviation from true decay corrected counts on phantoms and the constancy of monitor point-source counts in different patients' FOVs (root mean square error and maximum deviation) served as figures of merit. The accuracy of absorbed dose calculation was also estimated by comparison with the standard source correction method, computing the area under the time activity curve (AUC) of six lesions. RESULTS: With respect to the true phantom counts, corrected images gave excellent results, giving a 6% maximum deviation. For what concerns the other figures of merit, continuity DTC reduced the average root mean square error from 36% to 2% and the mean maximum deviation from 50% to 2%, on phantom, while from 51% to 32/28% (absence/presence of triple energy window scatter correction) and from 72% to 21/14% on patients. Mean compensation of AUC gave a correction of +56% with our method, while +78% with standard source method. CONCLUSIONS: The "Continuity DTC method" is a useful tool in dosimetry during nuclear medicine treatment, showing good accuracy. Moreover, since it does not require the use of any source, it provides with several advantages in terms of practicability and applicability, with respect to the standard source method and to methods based on the count rate characteristic curve.

Individualized dosimetry in the management of metastatic differentiated thyroid cancer.

AIM: This paper analyzes the available data on the dosimetric approach and describes the use of dosimetry in the Division of Nuclear Medicine of the National Cancer Institute in Milan. Dosimetry is rarely performed when planning radio-iodine activity, although most of the available guidelines do mention this possibility, without giving any well defined indication. Aim of the present research was to validate the usefulness of dosimetry in the management of metastatic thyroid cancer. Benua (1962) set the limit of blood absorbed dose at 2 Gy to avoid hematological toxicity. Maxon (1983) determined at 80 Gy the dose to achieve complete destruction of a metastatic lesion. Dorn (2003) combined red marrow and lesion dosimetry showing that high activity administrations with less that 3 Gy to the red marrow are a safe and more effective with respect to fixed activities administrations. Lee (2008) reported 50% responses with high activity administrations based on blood dosimetry, in 47 patients which were unsuccessfully previously treated with fixed activities. Sgouros (2005) and Song (2006) introduced key parameters as Biological Effective Dose and Uniform Equivalent Dose in order to describe the effects of continuous low dose rate irradiation and non uniform activity uptake, typical of nuclear medicine treatments. METHODS: Red marrow and lesion dosimetry (planar view) were performed during the treatment, without changing the fixed activity schema. RESULTS: This experience demonstrate first of all, that dosimetry is feasible in the clinical routine, and that it can provide the clinician with important information, no matter its often quoted limited numerical accuracy. A total of 17/20 lesion doses below 80 Gy have been detected. Three/17 (doses between 40 and 80 Gy) disappeared in the follow-up scintigram. Two/17 were undetectable at computed tomography or nuclear magnetic resonance. These data suggest that repetition of treatment on a lesion drastically reduces its uptake, with a loss of therapeutic efficacy along the sequence of fixed activity administrations. CONCLUSIONS: The usefulness of dosimetry should not be assessed only on the basis of patient survival or therapeutic efficacy; the possibility to avoid useless treatments should also be considered. According to the authors, individualized dosimetry could improve the management of metastatic differentiated thyroid cancer. Even post-therapeutic dosimetry, as performed at this institution, has a significant impact on clinical decision-making. The question for the future is how to include dosimetry into the patient management framework.

Renal limited Wegener's granulomatosis.

Differential diagnosis in patients presenting with fever of unknown origin (FUO) is often difficult because infectious diseases, neoplasms, infective endocarditis or systemic autoimmune diseases may all be responsible for the condition. Furthermore, vasculitis may generate typical, atypical or limited syndromes depending on the extent of vascular involvement. Here, we report the case of a 73-year-old man with FUO and renal failure due to a rare variant of Wegener's granulomatosis, limited to the kidneys.

Male osteoporosis.

Osteoporosis is a worldwide major public health problem, defined as "a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue with a consequent increase in bone fragility and susceptibility to fractures". Osteoporosis is diagnosed by bone mineral density measurement (T-score of -2.5 or below) also in men. However, most of the studies carried out in the last decade focused on pathogenesis, diagnosis and treatment of osteoporosis in women. In spite of this, recent epidemiological and observational studies have shown that osteoporosis in men is an increasingly important clinical issue. In part because the world population is aging, it is likely that the total number of hip fractures in men in 2025 will be similar to current estimates in women. Furthermore 25-33% of men in some populations will sustain osteoporotic fractures in their lifetime. Nevertheless, male osteoporosis is still underdiagnosed and further studies are required to clarify the pathogenesis and find out the right therapy. Prevention and early diagnosis are, nowadays, the best ways of treatment.

MIBG for diagnosis and therapy of medullary thyroid carcinoma: is there still a role?

Medullary thyroid carcinoma (MTC) is a relatively rare neuroendocrine tumour originating from the parafollicular C cells and releases calcitonin (hCt), carcinoembryonic antigen (CEA) and occasionally other substances. In 20-30% of cases MTC presents a germline mutation of the RET proto-oncogene and occurs in 3 different hereditary forms: familial MTC, multiple endocrine neoplasia (MEN) 2A and MEN 2B syndrome. Prognosis of MTC is largely related to tumour extension at disease onset. Surgery remains the most effective therapy for potential cure. Overall survival is strictly linked to the occurrence of relapse. After surgery, serum hCt remains the most sensitive test for occult disease. Diagnostic imaging work-up includes ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), bone scintigraphy, as the more frequent sites of recurrence or metastases are cervical and mediastinal lymph nodes, lungs, liver and bone. Nuclear medicine procedures include (111)In-labelled somatostatin analogs, radioiodinated metaiodobenzylguanidine (MIBG), and several PET radiopharmaceuticals. Experience with radionuclide therapy in MTC is restricted to few patients treated with (131)I-MIBG or (90)Y-DOTATOC. Since 1987, 1 027 diagnostic MIBG scans were performed in the Department Department of Diagnostic Imaging and Therapy of the Istituto Nazionale Tumori IRCCS Foundation (Milan, Italy), 85 of which for MTC, with a sensitivity of 38.7% in patients with evidence of disease and 30.7 % if all patients were considered. Since 1994, 13 MTC patients were treated with MIBG with 4 partial responses and 4 stable diseases. Patients with liver or bone involvement responded to therapy and showed long-term partial remission of disease, others showed stability of disease, which was apparently unrelated to therapy. Improvement of efficacy can be achieved through dosimetric calculation of administered activity.

[Splenic infarction after warfarin discontinuation during atrial fibrillation]. / Infarto splenico: rara complicanza tromboembolica di fi brillazione atriale.

We describe a case of patient with splenic infarction, admitted to our department for sudden abdominal pain and fever after discontinuation of anticoagulant therapy for atrial fibrillation, complicating a dilated myocardiopathy and mechanical prosthetic valve. Diagnosis of splenic infarction was made by enhanced-contrast computed tomography, while ultrasounds and radiography were negative. Anticoagulant therapy, gold-standard treatment, was followed by fast clinical improvement. Moreover, splenic infarction should be considered in all cases of acute or chronic pain in left hypochondrium and especially in patients with emboligenous cardiopathies or atrial fibrillation, the most common arrhythmia source of peripheral embolism in clinical practice.

Lymphoscintigraphy with intraoperative gamma probe sentinel node detection: clinical impact in patients with head and neck melanomas.

AIM: The aims of this paper were to evaluate the clinical relevance of lymphoscintigraphy with intraoperative gamma-probe detection in identifying sentinel nodes (SNs) and to study the prognostic value of SN biopsy in head and neck melanoma patients. METHODS: Sixty-one patients had lymphoscintigraphy with intradermal injections of 99mTc-Nanocoll (40 MBq), 24 h before surgery. Tumor-positive SNs patients underwent total lymph node dissection. Postoperative histological examination was performed. Patients were followed up for 1 to 5 years (median 3 years). The tumor relapses and the overall survival were evaluated by means of statistical methods. RESULTS: Lymphoscintigraphy showed lymphatic distribution to more than one basin in 45 patients (74%), in 15 patients one basin was visualized and no basin in 1 patient. In 41 patients the SN was negative for metastases, while in 20 was positive. In a high percentage of patients (30%), metastatic involvement occurred in more than one lymph node basin. During follow-up in the negative SN group, 40 patients remained disease free and 1 relapsed. In the positive SN group, 10 patients remained disease free and 10 relapsed. Recurrence time ranged from 6 to 11 months. The overall survival of the SNs negative group was significantly higher than the positive SN group. CONCLUSIONS: This approach was able to distinguish: a) patients with tumor-negative SNs with a favorable clinical course (98% did not relapse, P<0.001); b) patients with tumor-positive SNs with a high rate of tumor relapse (50%, P<0.001). Therefore SN biopsy may give information about prognosis in head and neck melanoma patients.

Comparative evaluation of two methods to assay thyroglobulin serum concentrations in patients with differentiated thyroid carcinomas.

AIM: This study was aimed at the comparative assessment of the analytical and clinical performances of 2 tests for thyroglobulin (Tg) assays: the Dynotest Tg-Plus immunoradiometric assay (IRMA), a new method that might be of interest for its claimed superior sensitivity compared to other methods, and the HTGK-2 IRMA, one of the test currently used in clinical routine. METHODS: The study was performed in serum samples from 157 patients with differentiated thyroid carcinoma (DTC). The clinical sensitivity of the test was evaluated in patients with and without thyroid stimulating hormone (TSH) suppression. RESULTS: The lowest detectable Tg concentration values and the within-assay coefficient of variation (CV) were 0.4 and 0.8 microg/L and 5% and 3% for the Dynotest Tg-Plus assay and the HTGK-2 assay, respectively; the between-assay CV was 6% for both assays. The clinical results of the Dynotest Tg-Plus and those of the HTGK-2 kit were similar in both DTC patient populations, either under or off the TSH suppressive treatment. In spite of the manufacturer's statement that the calibrators of both assays had been standardized against the same common reference (standard CRM 457 of the Community Bureau of References), the Dynotest Tg-Plus test underrated by a factor of 0.5 the Tg values measured by means of HTGK-2 IRMA. CONCLUSION: The sensitivity of the Dynotest Tg-Plus IRMA appears to be similar to that of the HTGK-2 assay.