Gallium-68 Prostate Specific Membrane Antigen for Ovarian Cancer: A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of gallium Ga 68-labeled PSMA-11 positron emission tomography (PET) positive lesions detected by standard staging scans
研究概览
简要总结
This trial studies how well gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga-PSMA) positron emission tomography (PET) works in patients with ovarian cancer to detect whether the tumor has spread to other places in the body. 68Ga-PSMA is a radioactive substance that binds to blood vessels around the ovarian cancer and can be imaged using PET. Diagnostic procedures, such as PET, may help find and diagnose find out how far the disease has spread.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility and utility of 68Ga-PSMA PET imaging patients with ovarian cancer.
II. Determine detection sensitivity for nodal metastases for PSMA PET stratified by node size.
SECONDARY OBJECTIVES:
I. To assess the correlation between targeted molecular uptake of 68Ga-PSMA PET and PSMA expression in surgical resection specimens.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with one of the following, identified on prior imaging (CT, MRI or Ultrasound):
- •adnexal mass
- •abdominal or pelvic tumor suspicious for ovarian cancer metastases (either suspected on clinical grounds, or known from prior tissue sampling)
- •Age >= 18 years
- •Creatinine </= 1.5 mg/dL
- •Ability to understand a written informed consent document, and the willingness to sign it
排除标准
- •Pregnant or breastfeeding women
- •Patient unlikely to comply with study procedure, restrictions and requirements and judged by the investigator to be unsuitable for study participation.
研究组 & 干预措施
Diagnostic 68Ga PSMA PET/MRI
Patients receive gallium Ga 68-labeled PSMA-11 IV over 1-2 minutes. After about 60 minutes, patients undergo PET/MRI for approximately over 50-60 minutes. Patients may undergo an optional repeat gallium Ga 68-labeled PSMA-11 PET between 8 and 12 weeks after completion of the first PET/MRI.
干预措施: Gallium Ga 68-labeled PSMA-11 (Drug)
Diagnostic 68Ga PSMA PET/MRI
Patients receive gallium Ga 68-labeled PSMA-11 IV over 1-2 minutes. After about 60 minutes, patients undergo PET/MRI for approximately over 50-60 minutes. Patients may undergo an optional repeat gallium Ga 68-labeled PSMA-11 PET between 8 and 12 weeks after completion of the first PET/MRI.
干预措施: Magnetic Resonance Imaging (MRI) (Procedure)
Diagnostic 68Ga PSMA PET/MRI
Patients receive gallium Ga 68-labeled PSMA-11 IV over 1-2 minutes. After about 60 minutes, patients undergo PET/MRI for approximately over 50-60 minutes. Patients may undergo an optional repeat gallium Ga 68-labeled PSMA-11 PET between 8 and 12 weeks after completion of the first PET/MRI.
干预措施: Positron Emission Tomography (PET) (Procedure)
结局指标
主要结局
Number of gallium Ga 68-labeled PSMA-11 positron emission tomography (PET) positive lesions detected by standard staging scans
时间窗: Study Visit Day 1
Will be descriptively reported for each patient and correlated with the lesions observed in standard imaging computed tomography/magnetic resonance imaging (CT/MRI). In addition, the mean, range, and standard deviation of standardized uptake value maximum (SUVmax) (across all visualized lesions per patient) and SUVmax-average (ave) (across all patients in the study cohort) will be descriptively reported.
Number of lymph nodes detected by PET
时间窗: Study Visit Day 1
Will be compared and stratified by lymph node size. For patients undergoing surgical resection, this will be compared with the number of involved lymph nodes by surgical resection. For lymph nodes that are not resected, the behavior on follow-up clinical CT scans (if available) will be used to assess for involvement.
Number of lymph nodes detected by MRI
时间窗: Study Visit Day 1
Will be compared and stratified by lymph node size. For patients undergoing surgical resection, this will be compared with the number of involved lymph nodes by surgical resection. For lymph nodes that are not resected, the behavior on follow-up clinical CT scans (if available) will be used to assess for involvement.
Number of overall ovarian cancer lesions detected by standard staging scans
时间窗: Study Visit Day 1
Will be descriptively reported for each patient and correlated with the lesions observed in standard imaging CT/MRI.
Average maximum standard uptake value (SUVmax)
时间窗: Study Visit Day 1
The mean, range, and standard deviation of SUVmax across all visualized lesions per patient will be descriptively reported.
次要结局
- Correlation between targeted molecular uptake of 68Ga-PSMA PET and prostate-specific membrane antigen (PSMA) expression in surgical resection specimens(Study Visit Day 1)
研究者
Michael Ohliger, MD
Assistant Professor
University of California, San Francisco