Medullary Thyroid Carcinoma Clinical Trial
Official title:
Evaluation of the Clinical Performance of 18F-FDOPA PET-CT in the Preoperative Initial Assessment of Medullary Thyroid Carcinoma: Multicenter Prospective Study
Medullary thyroid carcinoma (MTC) develops at the expense of calcitonin cells and is often
characterized by lymph node metastases and sometimes visceral metastases. Improvement of
preoperative diagnosis is of major importance in CMT because the quality of the initial
surgery determines the prognosis. In recent years, 18F-fluorodihydroxyphenylalanine
(18F-FDOPA) PET / CT was considered the most sensitive functional imaging tool in the
evaluation of persistent CMT. To date, 18F-FDOPA PET at initial diagnosis has been reported
in a few clinical cases.
The main objective is to demonstrate that 18F-FDOPA PET provides additional information
compared to conventional imaging on the initial diagnosis of CMT patients.
The secondary objectives are to describe the nature of the information provided by PET / CT
imaging, the main factors influencing tracer uptake and the positivity of PET / CT, and the
impact of the examination on the care of the patient.
This is a prospective, multicenter and open study.
Patients with TCM who have serum calcitonin> 150 pg / ml at initial diagnosis and have
performed baseline imaging examinations within the last 3 months will be included in the
study . A PET at 18F-FDOPA will be performed according to a very powerful acquisition
protocol. Image analysis will be performed blindly from the results of conventional imaging.
All exams will be compared, in accordance with the gold standard. Therapeutic intentions will
be collected before and after the PET imaging, as well as the actual management in place.
Medullary thyroid carcinoma (MTC) develops at the expense of calcitonin cells and is often
characterized by lymph node metastases (> 50% of cases) and sometimes visceral metastases (>
5%). Improvement of preoperative diagnosis is of major importance in CMT because the quality
of the initial surgery determines the prognosis. In recent years,
18F-fluorodihydroxyphenylalanine (18F-FDOPA) PET / CT was considered the most sensitive
functional imaging tool in the evaluation of persistent CMT. To date, 18F-FDOPA PET at
initial diagnosis has been reported in a few clinical cases. Preliminary study, which
included 9 CMT patients, 18F-FDOPA PET showed very promising results during the initial
diagnosis, particularly in node staging.
The main objective is to demonstrate that 18F-FDOPA PET provides additional information
compared to conventional imaging on the initial diagnosis of CMT patients. The secondary
objectives are to describe the nature of the information provided by PET / CT imaging, the
main factors influencing tracer uptake and the positivity of PET / CT, and the impact of the
examination on the care of the patient.
This is a prospective, multicenter and open study.
Patients with TCM who have serum calcitonin> 150 pg / ml at initial diagnosis and have
performed baseline imaging examinations (as recommended by the 2015 ATA) within the last 3
months will be included in the study . A PET at 18F-FDOPA will be performed according to a
very powerful acquisition protocol. Image analysis will be performed blindly from the results
of conventional imaging. All exams will be compared, in accordance with the gold standard.
Therapeutic intentions will be collected before and after the PET imaging, as well as the
actual management in place.
Number of patients expected: 62. Duration of the study: 29 months of inclusion and 7 months
of follow-up.
About 60 to 70 patients with a CMT are operated annually in the centers involved. Nuclear
physicians, endocrine surgeons, endocrinologists and anatomopathologists work together in
institutional and interinstitutional team meetings (SFE-RENATEN). Some of the centers have
already collaborated on the implementation of a large PHRC-INCa project recently published in
the JCEM.
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