Clinical trial · Interventional
Functional Microscale Organotypic Assays to Predict Patient Response to Anti-Angiogenesis Therapies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Termination of funding due to low subject enrollment due to change in standard of care systemic therapy which limited available patients treated with anti-angiogenesis or combined immune and anti-angiogenesis therapy for enrollment.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PSMA-based 18F-DCFPyL PET tracer for PET/CT exams | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-DCFPyL whole body PET/CT scan
- description
- 18F-DCFPyL whole body PET/CT scan at three time-points
- interventionNames
- Drug: PSMA-based 18F-DCFPyL PET tracer for PET/CT exams
Primary outcomes (4)
- measure
- Baseline Tumor FDG PET SUV Data by Disease Type at Baseline
- timeFrame
- Baseline
- description
- 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)
- measure
- Histopathological Endpoints: Immunohistochemical Staining for PSMA
- timeFrame
- Up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available