Preliminary Study of the Interest of Diffusion-weighted Magnetic Resonance Imaging in the Early Detection of Differentiated Thyroid Carcinoma Cervical Recurrence. Comparison with18F-FDG PET/CT
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Report of positive or negative results of detection of recurrent lesions from both dw-MRI and 18F-FDG PET/CT. data will be reported extensively and descriptively.
研究概览
简要总结
The purpose of the study is to evaluate the concordance between the 18F-PET/CT under thyrotropin stimulation and the diffusion-weighted Magnetic Resonance Imaging, in the detection of residual mass in 40 patients with partial response or relapsed differentiated thyroid carcinoma.
详细描述
The schedule and the procedures of the study are the following ones :
-
Baseline evaluation :
-
Clinical examination with neck echography after rhTSH stimulation
-
Normal whole body scan
-
First visit (inclusion):
18F-FDG PET/CT DW-MRI of the neck if possible performed shortly after the PET CT or within following days
-
Following visits: at 6 months and 12 months
-
DW-MRI of the neck performed shortly after the PET CT or within following days.
-
Ultrasonography guided fine needle aspiration for cytology for detection of cervical metastases and identifying thyroglobuline in the needle washout fluid if needed and in case of positivity of either PET or DW-MRI exams.
-
Histological assessment of biopsies if performed
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
- •Male or female,
- •Subjects must be 18 years of age or older,
- •Histologically confirmed papillary or follicular differentiated thyroid carcinoma with partial response or complete response, defined by
- •Thyroglobulin > 2 μg/L under thyrotrophin stimulation, four months after at least two 131-I based treatments (3,7 GBq/100mCi or more if optimal conditions),
- •Negative extension assessment (total body bone scan, (3,7 GBq/100 mCi or more)), echography, CT scan ( neck, thorax, abdomen): no findings..
- •Patient's Informed Consent form signed.
排除标准
- •History of previous cancer within the least three years,
- •Performance Status > 2,
- •Protected adults
- •Any medical, psychological, social or disabling conditions that could interfere or jeopardize the patient's participation
- •History of allergy to radio-iodine,
- •Estimated GFR < 45 ml/min /m² (MDRD method),
- •Women of childbearing potential without contraceptive method,
- •Uncontrolled diabetes mellitus,
- •Hypersensitivity to FDG or to any radio-tracers,
- •Contraindication to administration of Thyrogen® 0.9mg
- •Intraocular foreign bodies or any metallic foreign bodies that contraindicates the MRI.
- •Vascular clips, any object or implanted device that could interact with the ferromagnetic field,
- •Coronary and peripheral clips, aortic stent grafts, prosthetic heart valves, annuloplasty rings, vena cava filters, cardiac pacemaker, implantable cardiovascular defibrillators....,
- •Implanted insulin infuser
- •Neurostimulator device
- •Claustrophobia
- •Agitation or psychological trouble
研究组 & 干预措施
18F-FDG-PET and dw-MRI
At the inclusion, both all patients, a 18F-FDG-PET/CT and a dw-MRI will be performed
干预措施: PET (Device)
18F-FDG-PET and dw-MRI
At the inclusion, both all patients, a 18F-FDG-PET/CT and a dw-MRI will be performed
干预措施: MRI imaging (Device)
结局指标
主要结局
Report of positive or negative results of detection of recurrent lesions from both dw-MRI and 18F-FDG PET/CT. data will be reported extensively and descriptively.
时间窗: 1 year
To assess concordance between FDG PET-CT scan and MRI in detection of cervical residual masses in 40 patients in Partial Response or in relapse cervical well-differentiated thyroid carcinoma
次要结局
未报告次要终点