Functional Microscale Organotypic Assays to Predict Patient Response to Anti-Angiogenesis Therapies
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Baseline Tumor FDG PET SUV Data by Disease Type at Baseline
研究概览
简要总结
The primary objective of this research is to evaluate response to systemic therapy, including anti-angiogenesis therapy and/or immune-based therapies via 18F-DCFPyL prostate-specific membrane antigen (PSMA)-based positron emission tomography/computed tomography (PET/CT) in patients with metastatic renal cell carcinoma (RCC) and to compare qualitatively with conventional imaging response criteria - Response Evaluation Criteria In Solid Tumors (RECIST 1.1) and histopathological endpoints including isolation, enumeration and staining of Circulating Tumor Cells (CTC).
详细描述
Response of systemic therapy, including anti-angiogenesis therapy and/or immune-based therapies will be quantified using PSMA-based PET imaging using a novel agent,18F-DCFPyL, as a non-invasive imaging biomarker of tumor neovasculature to functionally monitor renal cell cancer neovasculature in patients undergoing systemic anti-angiogenesis therapy. PSMA PET will be compared with response to anti-angiogenesis therapy using conventional imaging computed tomography(CT)-based RECIST1.1 criteria as well as histopathological endpoints (tumor vascular density, immunohistochemical staining for PSMA and neovascularization (cluster of differentiation(CD)105, CD31). Whole body PSMA PET/CT scans will be obtained at baseline, following adjuvant anti- angiogenic therapy and when the patient becomes refractory to treatment.
The rationale and time points for obtaining PET scans is planned with respect to the typical natural history of metastatic RCC. This project will obtain information from tumors that are responding to anti-angiogenesis therapy and those resistant to treatment.
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
- •Patients diagnosed with locally advanced (>/=cT3) or metastatic clear cell RCC as proven by biopsy.
- •Adults, 18 years of age or older.
- •Surgical candidates who have clinical indication for nephrectomy and standard-of-care biopsy of metastatic disease followed by possible standard of care systemic anti-angiogenesis based treatment regimen
- •Have consented to participate in the University of Wisconsin Carbone Cancer Center Biobank.
排除标准
- •Patients who have received prior RCC systemic therapies
- •Prior history of prostate cancer
- •Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer
- •Unable to lie flat during or tolerate PET/CT
- •Serum creatinine > 2 times the upper limit of normal
研究组 & 干预措施
18F-DCFPyL whole body PET/CT scan
18F-DCFPyL whole body PET/CT scan at three time-points
干预措施: PSMA-based 18F-DCFPyL PET tracer for PET/CT exams (Drug)
结局指标
主要结局
Baseline Tumor FDG PET SUV Data by Disease Type at Baseline
时间窗: Baseline
Tumor FDG PET SUV data is provided from baseline PET tumor data. Participants with baseline 18F-DCFPyL PSMA PET/CT prior to surgical nephrectomy and metastatic disease sampling were analyzed based single timepoints for PET SUVmax values of tumor uptake (primary and metastatic disease)
Histopathological Endpoints: Immunohistochemical Staining for PSMA
时间窗: Up to 24 months
Compare PSMA imaging to histopathological endpoints which include tumor vascular density, immunohistochemical staining for PSMA and neovascularization (CD105, CD31 markers)
Histopathological Endpoints: Tumor Vascular Density
时间窗: Up to 24 months
Compare PSMA imaging to histopathological endpoints which include tumor vascular density, immunohistochemical staining for PSMA and neovascularization (CD105, CD31 markers)
Histopathological Endpoints: Neovascularization Measured by CD105 and CD31 Markers
时间窗: Up to 24 months
Compare PSMA imaging to histopathological endpoints which include tumor vascular density, immunohistochemical staining for PSMA and neovascularization (CD105, CD31 markers)
次要结局
- Measure Therapy Response of Patient Specific uVESSEL (a Micro Scale Organotypic Co-culture Model): Vessel Sprouting(Up to 24 months)
- Evaluate the Predictive Power and Validate the uVESSEL Model(Up to 24 months)
- Measure Therapy Response of Patient Specific uVESSEL (a Micro Scale Organotypic Co-culture Model): PMSA Expression(Up to 24 months)
- Measure Therapy Response of Patient Specific uVESSEL (a Micro Scale Organotypic Co-culture Model): Cell Death(Up to 24 months)