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

NCT00647140 | Terminated Phase 2

• 1 other identifier: P051081
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Neoplasm; Thyroid Carcinoma; Medullary Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

18F-L6DOPA PET

Other: 18F-L-DOPA PET

Interventions

18F-L-DOPA PET OTHER

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

Also known as: 18F-L-DOPA Positron Emission Tomography

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Antoine Beclere

Clamart, 92140, France

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Carcinoma, Medullary

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Study Officials

• Badia-Ourkia HELAL, MD

  Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: March 31, 2008
• Study Start: August 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: February 1, 2010
• Last Updated: July 7, 2010

Record last verified: 2010-05

Locations

FR (1)