Functional Microscale Organotypic Assays to Predict Patient Response to Anti-Angiogenesis Therapies (UW17104)

University of Wisconsin (UW)

Status and phase

Terminated

Phase 2

Conditions

Renal Cell Carcinoma

Treatments

Drug: PSMA-based 18F-DCFPyL PET tracer for PET/CT exams

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03387514

2017-1343

SMPH/RADIOLOGY/RADIOLOGY* (Other Identifier)

P30CA014520 (U.S. NIH Grant/Contract)

A539300 (Other Identifier)

Protocol Version 4/22/2019 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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