Study of PSMA-targeted 18F-DCFPyL PET/CT in the Evaluation of Patients With Renal Cell Carcinoma

Not Applicable

Completed

• Conditions: Renal Cell Carcinoma; Kidney Cancer
• Interventions: Drug: 18F-DCFPyL; Procedure: PET/CT

• Registration Number: NCT02687139
• Lead Sponsor: Johns Hopkins University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-02-11
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-22
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2020-04
• Results First Submitted: 2020-04-17
• Results First Submitted QC: 2020-04-17
• Last Update Submitted: 2020-04-17
• Results First Posted: 2020-04-29
• Last Update Posted: 2020-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-DCFPyL PET/CT	18F-DCFPyL	-
18F-DCFPyL PET/CT	PET/CT	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Correlation Between Radiotracer Uptake on 18F-DCFPyL PET/CT and Conventional Imaging	12 Months	This was assessed to Correlate Sites of Radiotracer Uptake on 18F-DCFPyL PET/CT With Conventional Imaging Findings.
Number of Participants With 18F-DCFPyL PET/CT Detected Sites of Metastatic Renal Cell Carcinoma (RCC)	12 Months	This was assessed to compare the sites of disease images of patients with RCC on conventional imaging with the images on the 18F-DCFPyL PET/CT to evaluate the sensitivity of DCFPyL PET/CT scans in detecting sites of disease compared to conventional imaging.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States