68Ga-NOTA-PEG2-RM26 PET/CT: Tracer Biodistribution and Uptake in Different Kinds of Cancer With Gastrin-Releasing Peptide Receptor (GRPR) Overexpression
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Adverse events within 2 weeks of injection
研究概览
简要总结
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-PEG2-RM26 in prostate cancer patients. A single dose of 2 MBq/kg of 68Ga-NOTA-PEG2-RM26 limited to 100-200 MBq per examination will be given intravenously. Visual and semiquantitative method will be used to assess PET/CT images.
详细描述
The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.
To target gastrin-releasing peptide receptor in human neoplastic cells NOTA-PEG2-RM26 was synthesised and then labeled with 68Ga.
An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-PEG2-RM26 and to assess its clinical diagnostic value in patients with cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Primary/recurrent or metastatic cancer in: prostate cancer, breast cancer, colorectal cancer, gastrointestinal carcinoid, gastric cancer, or lung cancer
- •Histopathological diagnosis
- •Age 18 years or more and palliative disease OR age above 50 years
- •Adequate bone marrow, hepatic and renal function, Eastern Cooperative Oncology Group Performance Status Scale 0 or 1 and a negative pregnancy test
排除标准
- •Age less than 18 years
- •Less than 6 months since a clinically significant cardiovascular event such as myocardial infarction, unstable angina, angioplasty, bypass surgery, stroke or transient ischemic attack
- •Congestive heart failure New York Heart Association class ≥ II
- •Pregnant or breast-feeding women
- •Patients with reproductive potential not implementing accepted and effective means of contraception
- •Participation in any other clinical trial within the previous 4 weeks
- •Unable to comply with study procedures (e.g., claustrophobia, low back pain not allowing the patient to lay down in the examination bed)
研究组 & 干预措施
68Ga-NOTA-PEG2-RM26
Participants will be injected with 2 MBq/kg of 68Ga-NOTA-PEG2-RM26 limited to 100-200 MBq and then undergo PET/CT examination.
干预措施: 68Ga-NOTA-PEG2-RM26 (Drug)
结局指标
主要结局
Adverse events within 2 weeks of injection
时间窗: 2 weeks
Adverse events within 2 weeks of injection and scanning of participants
次要结局
- Dosimetry of 68Ga-NOTA-PEG2-RM26(During procedure)
- Biodistribution of 68Ga-NOTA-PEG2-RM26(During procedure)
研究者
Jeffrey Yachnin M.D., PhD.
Section Head Early Clinical Trial Unit
Karolinska University Hospital