Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET ( Positron Emission Tomography) F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 10
- 主要终点
- Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment.
研究概览
简要总结
The aim of the trial is to study a radiating diagnosis agent used in post surgery when the biological assessment highlighted a residual disease.
This is an inter-regional multicentric, prospective study evaluating the benefit of PET F-DOPA imaging in involved node detection compared to standard imaging assessment in patient with medullary thyroid cancer.
The purpose of the study is to evaluate the impact and performance of a new PET / CT (computerized tomography ) tracer targeting dopamine receptor in patient with residual ganglionar biological disease after initial surgery of medullary thyroid cancer compared to standard imaging.
Obtained data will be compared to the "gold standard" based on :
- nodes cytology when they could be punctured
- histology when a new surgery will be recommended
- surveillance when the 2 first cases will be not applicable (imaging monitoring, evolution of thyrocalcitonin)
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
- •Age > or = 18 years.
- •Patient with medullary thyroid cancer (sporadic or hereditary form).
- •Patient treated by total thyroidectomy with uni or bi-lateral lymph node dissection (in the central and/or lateral neck compartment).
- •Patient with elevated thyrocalcitonin rate > or = 150 pg/ml assessed within 6 weeks or more after surgery.
- •Patient with standard imaging assessment performed during 3 months before PET 18-FDOPA.
- •Standard imaging assessment including at least a cervical ultra-sound, a cervico-thoracic CT-scan and/or a cervico-thoraco-abdomino-pelvic CT-scan and a liver MRI.
- •Patient able to be followed at least 6 months after PET 18-FDOPA.
- •If women are breastfeeding, nursing should be discontinued during 24 hours after PET 18-FDOPA.
- •Patient must provide written informed consent prior to any specific procedure or assessment.
- •Patient must be affiliated to the French Social Security System.
排除标准
- •Pregnant patient.
- •Post-operative radiotherapy initiated before PET 18-FDOPA.
- •Patient with PET 18-FDG performed within 24 hours before PET 18-FDOPA.
- •Participation in any other clinical trial for therapeutic use.
- •Patient with PET / CT-scan exam contra-indication.
- •Any serious and/or unstable pre-existing psychological, familial, geographic or social condition that could interfere with medical follow-up and compliance to study procedures.
- •Patient protected by law.
研究组 & 干预措施
PET 18-FDOPA
18F-DOPA will be administered with an activity of 1.5-4 MBq/kg (MegaBecquerel) in the IV (Intra venous) tubing to decrease the extravasation risk and tracer lymphatic migration. The injection site will be distant from pathologic area (forearm).
PET CT exam will start 10 min after tracer injection and will cover the whole body (10 to 30 min).
Other series of images will be done 50 min after tracer injection. Images will be interpreted.
干预措施: 18F-DOPA (Other)
结局指标
主要结局
Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment.
时间窗: up to 3 years
Analysis will be performed by node.
次要结局
- Relative rate of FALSE positive nodes with PET F-DOPA compared to standard imaging assessment.(up to 3 years)
- The concordance between the PET F-DOPA results of each centre and centralized review.(up to 3 years)
- Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment.(up to 3 years)
- Relative rate of TRUE positive and FALSE metastasis with PET F-DOPA compared to standard imaging assessment.(up to 3 years)
- Modification rate of patient's care after PET F-DOPA exam.(up to 3 years)