Pragmatic Study on the Use of 68Ga-DOTA-TATE PET|CT Imaging as a Standard of Care to Influence Clinical Management
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 4
- 主要终点
- Safety profile of 68Ga-DOTA-TATE
研究概览
简要总结
This clinical trial is a pragmatic study aiming to evaluate the innocuity/safety profile of the PET radiotracer 68Ga-DOTA-TATE, and to establish the procedure as a routine standard-of-care diagnostic tool for all neuro-endocrine cancer patients. It is a single-center study, but with recruitment across all Canada. The trial is prospective, non-randomized, open-label and with no control group. The superiority of this procedure over the former standard-of-care (Octreoscan) was already established in previous and numerous studies across the world. As such, the current trial aims to gather data to further support the implementation of 68Ga-DOTA-TATE as the new standard-of-care for neuro-endocrine tumors (NET).
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical requisition for a 68Ga-DOTA-TATE PET/CT signed by a referring doctor
- •Patients with suspected or proven tumors expressing somatostatin receptors
- •Informed consent by patient (or parents if patient is less than 18 years of age)
排除标准
- •*Pregnancy (not an absolute exclusion). See below*.
- •Patient refusal to participate.
- •Prior severe anaphylactic reaction to DOTA-TATE or somatostatin analogs.
- •In the case of a diagnostic procedure in a patient who is or may be pregnant, the principle of benefits-disadvantages would be applied following an in-depth discussion with the treating physicians and the patient. In this context, any clinical situation in which the patient's life would be at stake by excluding her from the study would be considered. The conditions to decide whether to include the patient would be:
- •Severe medical condition involving the life of the pregnant woman and/or the fetus;
- •Existing treatments that are ineffective or may present toxicity to the woman and/or fetus;
- •High clinical suspicion of a somatostatin receptor overexpressing tumour;
- •Negative, indeterminate or contraindicated first-line imaging tests;
- •Therapeutic gesture considered during pregnancy based on the results of the examination, which may include termination of pregnancy or premature delivery;
- •Documented discussion with the treating team and the patient;
- •Patient agrees.
结局指标
主要结局
Safety profile of 68Ga-DOTA-TATE
时间窗: 5 years
Following the injection, the patient will be explicitly reminded of possible symptoms and undesirable events. The patient will be advised to inform the study personnel of the occurrence of any events, at the most opportune time. The patient will be instructed to call the local nuclear medicine study coordinator for any undesirable event that may occur for 48 hours after the PET/CT scan. Safety will be assessed by compiling all reported adverse events. Adverse events reported by patients or observed by the investigator will be recorded in the patients' CRFs, the AE database, and reported to the research manager.
次要结局
- Generate clinical information on the impact of 68Ga-DOTA-TATE for NET patient management(5 years)
- Instigate the routine standard-of-care use of 68Ga-DOTA-TATE for NET patients(5 years)
研究者
Dr Éric E Turcotte, MD
Head of the clinical research, CIMS, CHUS
Centre de recherche du Centre hospitalier universitaire de Sherbrooke