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

NCT ID: NCT03387514

Last Updated: 2022-12-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-08

Study Completion Date

2021-06-29

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Renal Cell Carcinoma

Keywords

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Clear Cell Kidney Cancer RCC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This study is a single cohort study without randomization or stratification.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-DCFPyL whole body PET/CT scan

18F-DCFPyL whole body PET/CT scan at three time-points

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

* PET2A - Post-surgery and prior to start of standard of care systemic therapy
* PET2B - 12-16 weeks from start of first line systemic therapy (immune-based or anti-angiogenic)

PET3 - If first line systemic therapy did not include anti-angiogenesis therapy and new systemic therapy does include anti-angiogenesis therapy

* PET3A - Prior to start of additional anti-angiogenesis therapy
* PET3B - 12-16 weeks from the start of additional anti-angiogenesis therapy

PET4 - obtained at clinical progression or 2 years following initial systemic therapy

Interventions

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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

* PET2A - Post-surgery and prior to start of standard of care systemic therapy
* PET2B - 12-16 weeks from start of first line systemic therapy (immune-based or anti-angiogenic)

PET3 - If first line systemic therapy did not include anti-angiogenesis therapy and new systemic therapy does include anti-angiogenesis therapy

* PET3A - Prior to start of additional anti-angiogenesis therapy
* PET3B - 12-16 weeks from the start of additional anti-angiogenesis therapy

PET4 - obtained at clinical progression or 2 years following initial systemic therapy

Intervention Type DRUG

Other Intervention Names

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PSMA PET

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steve Cho, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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P30CA014520

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A539300

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/RADIOLOGY/RADIOLOGY*

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 4/22/2019

Identifier Type: OTHER

Identifier Source: secondary_id

2017-1343

Identifier Type: -

Identifier Source: org_study_id