PSMA Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging in Gynecological Cancers
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy
研究概览
简要总结
The goal of this research is to determine the accuracy of PSMA positron emission tomography (PET) and multi-parametric magnetic resonance (MR) imaging to detect the presence of gynecological cancer cells in the body.
详细描述
The investigators will evaluate a novel second-generation low-molecular-weight prostate specific membrane antigen (PSMA)-based positron emission tomography (PET) agent, 18F-DCFPyL, to determine the presence or absence of cancer, the accurate distribution of cancer and the normal biodistribution of PSMA in the abdomen and pelvis on PET imaging.
PSMA, also known as folate hydrolase 1 and glutamate carboxypeptidase II, is an enzyme associated with prostate cancer but has been also found to be expressed in the tumor neovasculature of many different types of non-prostate cancer tumors. PSMA-based 18F-DCFPyL PET demonstrates very high tumor-to-background ratio when studied in other tumors, including prostate tumors.
MR imaging is a highly sensitive and specific imaging modality that can be used for gynecologic cancers. MR images can be obtained in conjunction with PSMA PET, adding additional anatomic and multi-parametric MRI information without the need for a second imaging appointment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Women that are pregnant or breast-feeding.
- •Inability to provide informed consent on their own behalf
- •Severe kidney dysfunction (GFR <30 mL/min/1.73m2)
研究组 & 干预措施
Healthy Control Non-Dosimetry Group
The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6
干预措施: PSMA-based 18F-DCFPyL PET tracer (Drug)
Patient Group
The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40
干预措施: PSMA-based 18F-DCFPyL PET tracer (Drug)
Dosimetry Group
Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6
干预措施: PSMA-based 18F-DCFPyL PET tracer (Drug)
结局指标
主要结局
Diagnostic Accuracy
时间窗: up to 1 day
Estimate the frequency with which PSMA PET and MR imaging and final IHC staining disagree in their classifications of presence of disease.
次要结局
- Biodistribution of PSMA Measured by SUVmax in Normal Tissue(up to 1 day)
- Biodistribution of PSMA Measured by SUVmax in Cancer Tissue(up to 1 day)
- Radiodosimetry of PSMA(up to 1 day)
- Sensitivity and Specificity of PSMA-based PET/MR(up to 1 day)