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| Sponsor: | 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 |
| Study Type: | Interventional |
| 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. |
| Enrollment: | 29 |
| Study Start Date: | August 2007 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
18F-L6DOPA PET
|
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.
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| France | |
| Hôpital Antoine Beclere | |
| Clamart, France, 92140 | |
| Principal Investigator: | Badia-Ourkia HELAL, MD | Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère |
More Information
| Responsible Party: | Zakia.IDIR, Department Clinical Research of Developpemnt |
| ClinicalTrials.gov Identifier: | NCT00647140 History of Changes |
| Other Study ID Numbers: | P051081 |
| Study First Received: | March 26, 2008 |
| Last Updated: | July 6, 2010 |
| Health Authority: | France: Ministry of Health |
|
Thyroid neoplasm Thyroid carcinoma Medullary carcinoma Positron Emission Tomography (PET) 18F-L DOPA Calcitonin Carcinoembryonic Antibodies |
Cervical ultrasonography Cervical-chest-abdomen tomography Cervical-chest-abdomen magnetic resonance imaging Osseous radionuclide imaging Post-PET surgery Post-PET biopsy Post-PET histology |
|
Neoplasms Carcinoma Thyroid Neoplasms Thyroid Diseases Carcinoma, Medullary Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Endocrine Gland Neoplasms Neoplasms by Site Head and Neck Neoplasms Endocrine System Diseases Carcinoma, Neuroendocrine Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Nerve Tissue Dihydroxyphenylalanine Levodopa Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |