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

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Brief Title

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

Official Title

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

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.
    

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

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.


Condition

Thyroid Neoplasm

Intervention

18F-L-DOPA PET

Study Arms / Comparison Groups

 1
Description:  18F-L6DOPA PET

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

29

Start Date

August 2007

Completion Date

February 2010

Primary Completion Date

August 2009

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Badia-Ourkia HELAL, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00647140

Organization ID

P051081



Study Sponsor

Assistance Publique - Hôpitaux de Paris


Study Sponsor

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


Verification Date

May 2010