Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer

NCT ID: NCT00647140

Last Updated: 2010-07-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-02-28

Brief Summary

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.

Detailed Description

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.

Conditions

Thyroid Neoplasm; Thyroid Carcinoma; Medullary Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

18F-L6DOPA PET

Group Type: EXPERIMENTAL

18F-L-DOPA PET

Intervention Type: OTHER

PET performed 30 minutes after IV injection of 4 MBq/kg of 18F-DOPA

Interventions

18F-L-DOPA PET

PET performed 30 minutes after IV injection of 4 MBq/kg of 18F-DOPA

Intervention Type: OTHER

Other Intervention Names

18F-L-DOPA Positron Emission Tomography

Eligibility Criteria

Inclusion Criteria

• Patients up to 18 years old with medullary thyroid cancer / carcinoma
• Patients with medullary thyroid cancer / carcinoma recurrence, which have a high calcitonin level / rate, more than 100pg/ml, associated - or not - to a high CEA (Carcinoembryonic Antibodies) level / rate, dated from less than 3 months
• Patients with a less than 3 months conventional imaging checkup (cervical ultrasonography, cervical-chest-abdomen tomography and / or magnetic resonance imaging, abdomen ultrasonography, osseous / bones radionuclide imaging), in which the tumor site not certainty located
• Informed Consent Form signed and dated by patients
• Patients which are "SECURITE SOCIALE" affiliated

Exclusion Criteria

• Pregnant or suckling women
• Women able to procreate, without efficient birth control
• Patients already included in another Nuclear Medicine or Imaging research protocol using ionizing radiations; the efficient dose accumulation will not exceed 20 mSv.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Department Clinical Research of Developpemnt

Principal Investigators

Badia-Ourkia HELAL, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

Locations

Hôpital Antoine Beclere

Clamart, , France

Countries

France

Other Identifiers

P051081

Identifier Type: -

Identifier Source: org_study_id