Functional Microscale Organotypic Assays to Predict Patient Response to Anti-Angiogenesis Therapies (UW17104)
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|ClinicalTrials.gov Identifier: NCT03387514|
Recruitment Status : Completed
First Posted : January 2, 2018
Last Update Posted : October 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Drug: PSMA-based 18F-DCFPyL PET tracer for PET/CT exams||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study is a single cohort study without randomization or stratification.|
|Masking:||None (Open Label)|
|Official Title:||Functional Microscale Organotypic Assays to Predict Patient Response to Anti-Angiogenesis Therapies|
|Actual Study Start Date :||June 8, 2018|
|Actual Primary Completion Date :||June 29, 2021|
|Actual Study Completion Date :||June 29, 2021|
Experimental: 18F-DCFPyL whole body PET/CT scan
18F-DCFPyL whole body PET/CT scan at three time-points
Drug: PSMA-based 18F-DCFPyL PET tracer for PET/CT exams
18F-DCFPyL whole body PET/CT scan administered at the following timepoints:
PET1 - Prior to scheduled nephrectomy
PET2 - to establish a new baseline PET before systemic therapy
PET3 - If first line systemic therapy did not include anti-angiogenesis therapy and new systemic therapy does include anti-angiogenesis therapy
PET4 - obtained at clinical progression or 2 years following initial systemic therapy
Other Name: PSMA PET
- RECIST 1.1 Based Criteria [ Time Frame: Up to 24 months ]Compare number of lesions identified on PSMA versus standard of care imaging base on RECIST 1.1 criteria.
- HIstopathological Endpoints [ Time Frame: Up to 24 months ]Compare PSMA imaging to histopathological endpoints which include tumor vascular density, immunohistochemical staining for PSMA and neovascularization (CD105, CD31 markers)
- Measure therapy response of patient specific uVESSEL (a micro scale organotypic co-culture model) [ Time Frame: Up to 24 months ]Patient-derived uVESSEL models (from primary & metastatic sites) and incorporating patient-derived immune cells, will be tested for response to anti-angiogenic therapies including pazopanib, sunitinib, cabozantinib, and axitinib. Response will be quantified via multiple endpoints, e.g. vessel sprouting, PSMA expression, cell death.
- Evaluate the predictive power and validate the uVESSEL model [ Time Frame: Up to 24 months ]Using the clinical, pathological and imaging endpoints, predictive models will e developed using responses to uVESSEL model above. More specifically the objective response (dichotomous endpoint of yes or no) measured using PSMA-based PET/CT will be used as a dependent variable in a logistic regression model with response to uVESSEL model from above as an independent predictor to segregate uVESSEL responses into two groups corresponding to responders and non-responders to anti-angiogenic therapies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387514
|United States, Wisconsin|
|University of Wisconsin Carbone Cancer Center|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Steve Cho, MD||University of Wisconsin, Madison|