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| Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00647140 |
Purpose
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.
| Condition | Intervention | Phase |
|
Thyroid Neoplasm Thyroid Carcinoma Medullary Carcinoma |
Other: 18F-L-DOPA PET |
Phase II |
| MedlinePlus related topics: | Cancer Nuclear Scans Thyroid Cancer |
| ChemIDplus related topics: | Thyroid Levodopa Calcitonin Calcitonin human Fortical |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer. |
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
18F-L6DOPA PET
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Other: 18F-L-DOPA PET
PET performed 30 minutes after IV injection of 4 MBq/kg of 18F-DOPA
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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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| Contact: Badia-Ourkia HELAL, MD | +33(0)1-4537 4838 | badia.helal@abc.aphp.fr |
| France | |||||
| Hôpital Antoine Beclere | Recruiting | ||||
| CLAMART, France, 92140 | |||||
| Contact: Badia-Ourkia HELAL, MD +33(0)1-4537 4838 badia.helal@abc.aphp.fr | |||||
| Assistance Publique - Hôpitaux de Paris |
| Principal Investigator: | Badia-Ourkia HELAL, MD | Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère |
More Information
| Responsible Party: | Department Clinical Research of Developpemnt ( Zakia.IDIR ) |
| Study ID Numbers: | P051081, AOM05169, 07-004 |
| First Received: | March 26, 2008 |
| Last Updated: | March 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00647140 |
| Health Authority: | France: Ministry of Health |
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