Trial Outcomes & Findings for Study of PSMA-targeted 18F-DCFPyL PET/CT in the Evaluation of Patients With Renal Cell Carcinoma (NCT NCT02687139)

Last Updated: 2020-04-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

12 Months

Results posted on

2020-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	18F-DCFPyL PET/CT 18F-DCFPyL PET/CT: Positron Emission Tomography - Computed Tomography (PET/CT)
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	18F-DCFPyL PET/CT n=34 Participants Men and women of all races and ethnic groups are eligible for this study were encouraged to participate.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	18F-DCFPyL PET/CT n=34 Participants 18F-DCFPyL PET/CT: Positron Emission Tomography - Computed Tomography (PET/CT)
Number of Participants With 18F-DCFPyL PET/CT Detected Sites of Metastatic Renal Cell Carcinoma (RCC)	34 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: Only the first 14 participants enrolled in this study were assessed for this outcome and published at the time.

This was assessed to Correlate Sites of Radiotracer Uptake on 18F-DCFPyL PET/CT With Conventional Imaging Findings.

Outcome measures

Outcome measures
Measure	18F-DCFPyL PET/CT n=14 Participants 18F-DCFPyL PET/CT: Positron Emission Tomography - Computed Tomography (PET/CT)
Number of Participants With a Correlation Between Radiotracer Uptake on 18F-DCFPyL PET/CT and Conventional Imaging	4 Participants

Adverse Events

18F-DCFPyL PET/CT

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	18F-DCFPyL PET/CT n=34 participants at risk 18F-DCFPyL PET/CT: Positron Emission Tomography - Computed Tomography (PET/CT)
Nervous system disorders Headache	5.9% 2/34 • Number of events 2 • 1 year
Gastrointestinal disorders Constipation	2.9% 1/34 • Number of events 1 • 1 year
Gastrointestinal disorders Nausea	2.9% 1/34 • Number of events 1 • 1 year

Additional Information

Mohamad Allaf, MD

Johns Hopkins University

Phone: 410-502-7710

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place