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

Johns Hopkins University

Status: Completed

Conditions: Kidney Cancer; Renal Cell Carcinoma

Treatments: Drug: 18F-DCFPyL; Procedure: PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT02687139

IRB00075596

Details and patient eligibility

About

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).

Enrollment: 34 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

18F-DCFPyL PET/CT

Experimental group

Treatment:

Procedure: PET/CT

Drug: 18F-DCFPyL