- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03387514
Functional Microscale Organotypic Assays to Predict Patient Response to Anti-Angiogenesis Therapies (UW17104)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin Carbone Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 18F-DCFPyL whole body PET/CT scan
18F-DCFPyL whole body PET/CT scan at three time-points
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Tumor FDG PET SUV Data by Disease Type at Baseline
Time Frame: 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)
|
Baseline
|
Histopathological Endpoints: Immunohistochemical Staining for PSMA
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)
|
Up to 24 months
|
Histopathological Endpoints: Tumor Vascular Density
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)
|
Up to 24 months
|
Histopathological Endpoints: Neovascularization Measured by CD105 and CD31 Markers
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)
|
Up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure Therapy Response of Patient Specific uVESSEL (a Micro Scale Organotypic Co-culture Model): Vessel Sprouting
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.
|
Up to 24 months
|
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.
|
Up to 24 months
|
Measure Therapy Response of Patient Specific uVESSEL (a Micro Scale Organotypic Co-culture Model): PMSA Expression
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.
|
Up to 24 months
|
Measure Therapy Response of Patient Specific uVESSEL (a Micro Scale Organotypic Co-culture Model): Cell Death
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.
Two subjects had data collected and were assessed.
|
Up to 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Steve Cho, MD, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-1343
- A539300 (Other Identifier: UW Madison)
- P30CA014520 (U.S. NIH Grant/Contract)
- SMPH/RADIOLOGY/RADIOLOGY* (Other Identifier: UW Madison)
- Protocol Version 4/22/2019 (Other Identifier: UW Madison)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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