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

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

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.

Study Overview

• Status: Terminated
• Conditions: Thyroid Carcinoma; Thyroid Neoplasm; Medullary Carcinoma
• Intervention / Treatment: Other: 18F-L-DOPA PET

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Clamart, France, 92140
    • Hôpital Antoine Béclère

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 18F-L-DOPA Positron Emission Tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	At the 18F-L-DOPA PET and 1 year

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Badia-Ourkia HELAL, MD, Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: March 26, 2008
• First Submitted That Met QC Criteria: March 28, 2008
• First Posted (Estimate): March 31, 2008

Study Record Updates

• Last Update Posted (Estimate): July 7, 2010
• Last Update Submitted That Met QC Criteria: July 6, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Thyroid carcinoma; Positron Emission Tomography (PET); Calcitonin; Medullary carcinoma; Thyroid neoplasm; 18F-L DOPA; 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
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Carcinoma, Neuroendocrine; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma; Thyroid Diseases; Thyroid Neoplasms; Carcinoma, Medullary; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Levodopa
• Other Study ID Numbers: P051081