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

This study has been terminated.
(Insuffisent recruitment)
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00647140
First received: March 26, 2008
Last updated: July 6, 2010
Last verified: May 2010
  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 2

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.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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. [ Time Frame: At the 18F-L-DOPA PET and 1 year ] [ Designated as safety issue: No ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647140

Locations
France
Hôpital Antoine Beclere
Clamart, France, 92140
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Badia-Ourkia HELAL, MD Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
  More Information

No publications provided

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

Keywords provided by Assistance Publique - Hôpitaux de Paris:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on April 22, 2014