GATED-PET Heart Analysis in Patients Having a Gallium-68--DOTATOC PET/CT Exam for Oncology Indication
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Relationship between the captation of radiotracer and the cardiovascular disease
研究概览
简要总结
Gallium-68-DOTATOC binds primarily with high affinity to somatostatin subtype 2 (SSTR2) receptors and these somatostatin receptors are also overexpressed on inflammation cells when activated.
The hypothesis is that the GATED mode on a Gallium-68-DOTATOC cardiac recording would be able to highlight abnormalities that could be correlated with the age of the patients and their cardiovascular risk factors.
详细描述
People with the selection criteria for the study, coming to the nuclear medicine department in order to benefit from a Gallium-68-DOTATOC PET/CT exam as part of a diagnostic or pre-therapeutic assessment of a neuroendocrine tumor will be offer to participate in the study After sign consent, patients were install in a room to have blood drawn for Troponin Ic, BNP and CRP and after Gallium-68-DOTATOC infusion Gallium-68-DOTATOC PET/CT will be recorded and immediately the cardiac record in Gated mode
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
- •Persons who have received complete information on the organization of the research and who have signed the informed consent and:
- •Age ≥ 18 years old.
- •Having read and understood the information document.
- •Affiliated to a social security scheme.
- •Person for whom a 68Ga-DOTATOC PET/CT exam is requested as part of the diagnostic or pre-therapeutic assessment of a neuroendocrine tumour.
排除标准
- •Person with
- •Hypersensitivity during previous use of 68Ga-DOTATOC
- •Impossibility of performing a PET-CT (patient agitated, confused, etc.).
- •History of heart disease,
- •Severe arrhythmia that does not allow the PET synchronized with the ECG
- •Severe renal insufficiency (GFR <30 ml/min/1.73 m2)
- •Treated with a somatostatin analogue.
- •Cushing's syndrome
- •Pregnant woman, likely to be or breastfeeding
- •Adult subject to a legal protection measure (guardianship, curators, legal safeguard)
- •Person of legal age unable to express their consent
- •Person deprived of liberty by a judicial or administrative decision
- •Person, subject to psychiatric care under articles L. 3212-1 and L. 3213-1
研究组 & 干预措施
Patients
Person for whom a 68Ga-DOTATOC PET/CT exam is requested as part of the diagnostic or pre-therapeutic assessment of a neuroendocrine tumor
干预措施: Cardiac ECG-gated PET imaging will added (Other)
结局指标
主要结局
Relationship between the captation of radiotracer and the cardiovascular disease
时间窗: 1 day
Measurement of myocardial activity
次要结局
- Relationship between the captation of radiotracer and the troponin value(1 day)
研究者
Mathieu PERRIN
MD
Central Hospital, Nancy, France