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Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer (DOPMET)
This study is currently recruiting participants.
Study NCT00647140   Information provided by Assistance Publique - Hôpitaux de Paris
First Received: March 26, 2008   Last Updated: January 28, 2009   History of Changes

March 26, 2008
January 28, 2009
August 2007
July 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00647140 on ClinicalTrials.gov Archive Site
 
 
 
Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer
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.

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.

Phase II
Interventional
Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
  • Thyroid Neoplasm
  • Thyroid Carcinoma
  • Medullary Carcinoma
Other: 18F-L-DOPA PET
Experimental: 18F-L6DOPA PET
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
July 2011
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Badia-Ourkia HELAL, MD +33(0)1-4537 4838 badia.helal@abc.aphp.fr
France
 
NCT00647140
Zakia.IDIR, Department Clinical Research of Developpemnt
P051081, AOM05169, 07-004
Assistance Publique - Hôpitaux de Paris
 
Principal Investigator: Badia-Ourkia HELAL, MD Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
Assistance Publique - Hôpitaux de Paris
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP