N/A
N=34
Study of PSMA-targeted 18F-DCFPyL PET/CT in the Evaluation of Patients With Renal Cell Carcinoma
Renal Cell Carcinoma · Kidney Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02687139 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Number of Participants With 18F-DCFPyL PET/CT Detected Sites of Metastatic Renal Cell Carcinoma (RCC) — 34 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 18F-DCFPyL (Drug); PET/CT (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 18F-DCFPyL PET/CT Detected Sites of Metastatic Renal Cell Carcinoma (RCC) |
34 | — |
| PRIMARY Number of Participants With a Correlation Between Radiotracer Uptake on 18F-DCFPyL PET/CT and Conventional Imaging |
4 | — |
Summary
In this study the investigators aim to evaluate diagnostic utility of prostate-specific membrane antigen (PSMA)-targeted 18F-DCFPyL PET/CT in patients with renal cell carcinoma (RCC).
Eligibility Criteria
Inclusion Criteria
- Clinically diagnosed or histologically proven stage II-IV renal cell carcinoma
- Completed staging evaluation with computed tomography (CT) or magnetic resonance imaging (MRI) of the chest, abdomen and pelvis ≤90 days prior to study enrollment
Exclusion Criteria
- History of other malignancy diagnosed within the last 3 years (with the exception of low risk prostate cancer, ductal carcinoma in situ of the breast, squamous cell carcinoma or basal cell carcinoma of the skin)
- Administered a radioisotope within 5 physical half-lives prior to study enrollment
- Pregnancy ((as determined in accordance with the policies of the positron emission tomography (PET) center))
- Intention to enroll in a blinded therapeutic clinical trial following Positron emission tomography-computed tomography (PET/CT)
Data sourced from ClinicalTrials.gov (NCT02687139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.