A Pilot Study of 68-Ga-RM2 PET/MRI in the Evaluation of Patients With Estrogen Receptor-Positive Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Detection of ER Positive Breast Cancer and Metastases on 68-Ga RM2 PET/MRI
研究概览
简要总结
This trial studies how well 68-Ga RM2 works with PET/MRI in imaging patients with estrogen receptor-positive breast cancer. 68-Ga-RM2 is an agent used in diagnostic imaging.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of 68-Ga RM2 PET/MRI for identification of estrogen receptor positive primary breast cancer and metastases
OUTLINE:
Patients receive 68-Ga-RM2 intravenously (IV) and after 45 minutes undergo PET/MRI over 30-60 minutes.
After completion of study, patients are followed up at 24-72 hours, and then for 12 months.
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
- •ER+ breast cancer at initial diagnosis prior to surgery or at recurrence (at least one ER+ lesion based on results of biopsy).
- •Able to provide written consent
- •Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent)
排除标准
- •Less than 18 years-old at the time of radiotracer administration
- •Inability to lie still for the entire imaging time
- •Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- •Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
- •Renal function impairment preventing administration of MRI contrast
- •Metallic implants (contraindicated for MRI)
研究组 & 干预措施
Diagnostic (68-Ga RM2, PET/MRI)
Patients receive 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes.
干预措施: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548 (Drug)
Diagnostic (68-Ga RM2, PET/MRI)
Patients receive 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes.
干预措施: Magnetic Resonance Imaging (Procedure)
Diagnostic (68-Ga RM2, PET/MRI)
Patients receive 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes.
干预措施: Positron Emission Tomography (Procedure)
Diagnostic (68-Ga RM2, PET/MRI)
Patients receive 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes.
干预措施: Investigational software and coils in PET/MR scan (Device)
结局指标
主要结局
Detection of ER Positive Breast Cancer and Metastases on 68-Ga RM2 PET/MRI
时间窗: up to 2 hours
Number of lesions identified on 68-Ga RM2 positron emission tomography/magnetic resonance imaging (PET/MRI). The outcome will be reported as the number of participants with successful PET based detection of estrogen receptor (ER) positive breast cancer and metastases.
次要结局
未报告次要终点
研究者
Andrei Iagaru
Professor of Radiology (Nuclear Medicine) at the Stanford University Medical Center
Stanford University