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Clinical Trials/NCT02687139
NCT02687139
Completed
N/A

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

Johns Hopkins University1 site in 1 country34 target enrollmentOctober 2015

Overview

Phase
N/A
Intervention
18F-DCFPyL
Conditions
Renal Cell Carcinoma
Sponsor
Johns Hopkins University
Enrollment
34
Locations
1
Primary Endpoint
Number of Participants With a Correlation Between Radiotracer Uptake on 18F-DCFPyL PET/CT and Conventional Imaging
Status
Completed
Last Updated
6 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
April 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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)

Arms & Interventions

18F-DCFPyL PET/CT

Intervention: 18F-DCFPyL

18F-DCFPyL PET/CT

Intervention: PET/CT

Outcomes

Primary Outcomes

Number of Participants With a Correlation Between Radiotracer Uptake on 18F-DCFPyL PET/CT and Conventional Imaging

Time Frame: 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)

Time Frame: 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.

Study Sites (1)

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