Comparison of a 3D Recording in a VERITON-CT™ Camera to the Anger Camera Procedure in Patients Treated by Iodine 131 for a Thyroid Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Compare post-therapy imaging performed with the two procedures
研究概览
简要总结
The aim of this study is to show that the SPECT/CT whole body recording procedure lasting less than or equal to 30 minutes in a VERITON-CT™ camera, can be substituted for the classic procedure, giving at least equivalent information in searches for primary or metastatic neoplastic lesions.
详细描述
Patients with thyroid cancer treated with iodine 131 will receive an iodine 131 activity of between 1100 and 3700 MBq delivered as a capsule orally to eliminate the remaining thyroid tissue. Hormone replacement therapy (HRT) is then started to correct the hypothyroidism.
3 days later, a 2D whole body recording will be associated with complementary Single Photonic Emission Computed Tomography CT scans (SPECT/CT). It enables visualising the fixation of iodine 131, provides information on the thyroid remnants left in place during surgical thyroidectomy and to carry out an extension assessment by visualizing the possible presence of metastases fixing iodine at the level of the regional lymph nodes or many distant sites, in particular, lung and bone.
In VERICATH study, the hypothesis is that this classic procedure could be advantageously replaced by a single full-body SPECT/CT recording of a limited duration (≤ 30 minutes), obtained with a camera state-of-the-art semiconductor device called the VERITON-CT™ (Spectrum Dynamics Medical) camera.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patients over the age of 18, who have understood and signed the informed consent form.
- •Person suffering from thyroid cancer and for whom the multidisciplinary meeting has validated a treatment by iodine 131 (1100 MBq or 3700 MBq).
- •Person with no contraindication to carrying out the examination.
- •Person affiliated to a social security scheme.
排除标准
- •Person with a known allergy to one of the components of the radiopharmaceutical (Iodine 131 capsule).
- •Pregnant woman or woman of childbearing age and without suitable contraceptive means, or breastfeeding mother.
- •Person whose medical condition is unstable and/or unable to remain still in the supine position during recordings.
- •Person deprived of liberty by a judicial or administrative decision.
- •Person of full age subject to a measure of legal protection (guardianship, curators, safeguard of justice).
- •Adult person unable to express his consent and who is not the subject of a legal protection measure.
结局指标
主要结局
Compare post-therapy imaging performed with the two procedures
时间窗: 18 months
Type of lesions * Lesions * The nature of the lesion(s): thyroid residue and/or lymph node lesion and/or metastases (distant lesions). * Number of lesions in conventional camera and in VERITON-CT™ camera.
次要结局
- Compare the two procedures in terms of cancer status result.(18 months)
- Determine the feasibility of a 3D quantification of the fixation of thyroid residues in a VERITON-CT™ camera(18 months)
- Evaluate the two exams in terms of ergonomics for technologists(18 months)
研究者
Elodie CHEVALIER
Principal investigator
Central Hospital, Nancy, France