Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer (DOPMET)
Medullary thyroid carcinoma (MTC) is a rare tumor arising from C cells of the thyroid gland and belonging to the endocrine tumors. 18F-DOPA PET, based on tha capacity of endocrine tumor cells to take-up, decarboxylate and store amino-acids, such 3-4-dihydroxyphenylalanine(DOPA), is used for imaging endocrine tumors. The aim of the study was to evaluate the contribution of 18F-DOPA whole-body PET for the detection of recurrences in patients with proven recurrent MTC without evidence of recurrence or metastases on several imaging modalities.
Other: 18F-L-DOPA PET
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer.|
- Any tracer accumulation exceeding the normal uptake tissue searched by two experienced nuclear medicine physicians and compared by malignant tissue confirmed by histology after biopsy, surgery or by follow-up for one year. [ Time Frame: At the 18F-L-DOPA PET and 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||February 2010|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Other: 18F-L-DOPA PET
PET performed 30 minutes after IV injection of 4 MBq/kg of 18F-DOPA
Other Name: 18F-L-DOPA Positron Emission Tomography
In patients MTC and persistently elevated calcitonin levels, the challenge is finding the site of residual disease. Since the only satisfying treatment is surgery, the early detection and precise location is important. Tumor localization techniques usually performed, including ultrasonography of the neck and liver, chest and abdomen, bone scintigraphy, isotopic scanning and even PET with FDG are poorly sensitive. The use of 18F-DOPA may be more sensitive and specific engineering for localization metastatic disease. The study include 100 patient with persistent MTC demonstrated by elevated tumor markers (calcitonin and CEA) and no evidence of recurrence on morphological imaging procedures. 18F-DOPA whole-body PET is performed 30 minutes after IV injection of 4 MBq/kg of 18F-DOPA, the patient fasted for 6 hours prior the start of the examination.
All 18F-DOPA PET are evaluated independently by two experienced nuclear medicine physicians and any tracer accumulation exceeding the normal uptake tissue is rated as pathologic finding. The sensibility and efficiency of 18F-DOPA PET will be analysed and Malignant tissue confirmed by histology after surgery or biopsy or by follow-up for one year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647140
|Hôpital Antoine Beclere|
|Clamart, France, 92140|
|Principal Investigator:||Badia-Ourkia HELAL, MD||Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère|