Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer.
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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
No
Badia-Ourkia HELAL, MD
Principal Investigator
Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
France: Ministry of Health
P051081
NCT00647140
August 2007
February 2010
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