Evaluation of the Clinical Performance of 18F-FDOPA PET-CT in the Preoperative Initial Assessment of Medullary Thyroid Carcinoma: Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- number of patient with aditionnal information
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pregnant women (positive pregnancy test) or lactating women can not be included.
研究组 & 干预措施
Medullary thyroid carcinoma
Patients with MTC 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
干预措施: PET at 18F-FDOPA (Other)
结局指标
主要结局
number of patient with aditionnal information
时间窗: 90 MINUTES
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.
次要结局
未报告次要终点