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

This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, October 2007

Sponsored by: 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

MedlinePlus related topics:   Cancer    Nuclear Scans    Thyroid Cancer   

ChemIDplus related topics:   Thyroid    Levodopa    Calcitonin    Calcitonin human    Fortical   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer.

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 ]

Estimated Enrollment:   100
Study Start Date:   August 2007
Estimated Study Completion Date:   July 2011
Estimated Primary Completion Date:   July 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
18F-L6DOPA PET
Other: 18F-L-DOPA PET
PET performed 30 minutes after IV injection of 4 MBq/kg of 18F-DOPA

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

Contacts
Contact: Badia-Ourkia HELAL, MD     +33(0)1-4537 4838     badia.helal@abc.aphp.fr    

Locations
France
Hôpital Antoine Beclere     Recruiting
      CLAMART, France, 92140
      Contact: Badia-Ourkia HELAL, MD     +33(0)1-4537 4838     badia.helal@abc.aphp.fr    

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


Responsible Party:   Department Clinical Research of Developpemnt ( Zakia.IDIR )
Study ID Numbers:   P051081, AOM05169, 07-004
First Received:   March 26, 2008
Last Updated:   March 28, 2008
ClinicalTrials.gov Identifier:   NCT00647140
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

Study placed in the following topic categories:
Calcitonin
Levodopa
Carcinoma, Medullary
Thyroid Neoplasms
Carcinoma, Neuroendocrine
Endocrine System Diseases
Salmon calcitonin
Carcinoma
Neuroendocrine Tumors
Calcitonin Gene-Related Peptide
Neuroectodermal Tumors
Antibodies
Dopamine
Head and Neck Neoplasms
Neoplasms, Germ Cell and Embryonal
Thyroid cancer, medullary
Dihydroxyphenylalanine
Neuroepithelioma
Endocrinopathy
Adenocarcinoma
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neurotransmitter Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Antiparkinson Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Dopamine Agents
Neoplasms, Ductal, Lobular, and Medullary
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008




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