Medullary Thyroid Carcinoma Clinical Trial
— TEPCMTOfficial 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.
Status | Not yet recruiting |
Enrollment | 62 |
Est. completion date | September 2021 |
Est. primary completion date | March 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Major patient, affiliated to a social security scheme and having signed a written consent - Patients with CMT (initial diagnosis) - Serum calcitonin> 150 µg / ml - Patient who had the baseline imaging assessment during the 3 months preceding the 18F-FDOPA PET scan (as recommended by the 2015 ATA (11)), according to the serum calcitonin level: - 150 <Calcitonin <500: cervical ultrasound + cervico-thoracic CT scan - Calcitonin =500: cervical ultrasound, cervico-thoracoabdominopelvic CT scan, bone MRI. Exclusion Criteria: - Pregnant women (positive pregnancy test) or lactating women can not be included. |
Country | Name | City | State |
---|---|---|---|
France | Assistance Publique Des Hopitaux de Marseille | Marseille | Paca |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique Hopitaux De Marseille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of patient with aditionnal information | the proportion of CMT patients for whom 18F-FDOPA PET / CT PET provides additional information compared to the conventional imaging (CI) assessment at the initial diagnosis. | 90 MINUTES |
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