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

• ClinicalTrials.gov Identifier: NCT02687139
• Recruitment Status: Completed
• First Posted: February 22, 2016
• Results First Posted: April 29, 2020
• Last Update Posted: April 29, 2020
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Conditions: Renal Cell Carcinoma; Kidney Cancer
• Interventions: Drug: 18F-DCFPyL; Procedure: PET/CT
• Enrollment: 34

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	18F-DCFPyL PET/CT
Arm/Group Description	18F-DCFPyL PET/CT: Positron Emission Tomography - Computed Tomography (PET/CT)
Period Title: Overall Study
Started	34
Completed	34
Not Completed	0

Baseline Characteristics

Arm/Group Title		18F-DCFPyL PET/CT
Arm/Group Description		Men and women of all races and ethnic groups are eligible for this study were encouraged to participate.
Overall Number of Baseline Participants		34
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	9 26.5%
	>=65 years	25 73.5%
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	34 participants
		60; (18 to 76)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants
	Female	10 29.4%
	Male	24 70.6%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants
	Hispanic or Latino	1 2.9%
	Not Hispanic or Latino	31 91.2%
	Unknown or Not Reported	2 5.9%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants
	American Indian or Alaska Native	0 0.0%
	Asian	1 2.9%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	31 91.2%
	More than one race	0 0.0%
	Unknown or Not Reported	2 5.9%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	34 participants
		34 100.0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With 18F-DCFPyL PET/CT Detected Sites of Metastatic Renal Cell Carcinoma (RCC)
Description	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.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	18F-DCFPyL PET/CT
Arm/Group Description:	18F-DCFPyL PET/CT: Positron Emission Tomography - Computed Tomography (PET/CT)
Overall Number of Participants Analyzed	34
Measure Type: Count of Participants; Unit of Measure: Participants
	34 100.0%

2. Primary Outcome

Title	Number of Participants With a Correlation Between Radiotracer Uptake on 18F-DCFPyL PET/CT and Conventional Imaging
Description	This was assessed to Correlate Sites of Radiotracer Uptake on 18F-DCFPyL PET/CT With Conventional Imaging Findings.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	18F-DCFPyL PET/CT
Arm/Group Description:	18F-DCFPyL PET/CT: Positron Emission Tomography - Computed Tomography (PET/CT)
Overall Number of Participants Analyzed	14
Measure Type: Count of Participants; Unit of Measure: Participants
	4 28.6%

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	18F-DCFPyL PET/CT
Arm/Group Description	18F-DCFPyL PET/CT: Positron Emission Tomography - Computed Tomography (PET/CT)
All-Cause Mortality
	18F-DCFPyL PET/CT
	Affected / at Risk (%)
Total	0/34 (0.00%)
Serious Adverse Events
	18F-DCFPyL PET/CT
	Affected / at Risk (%)	# Events
Total	0/34 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	18F-DCFPyL PET/CT
	Affected / at Risk (%)	# Events
Total	3/34 (8.82%)
Gastrointestinal disorders
Constipation †	1/34 (2.94%)	1
Nausea †	1/34 (2.94%)	1
Nervous system disorders
Headache † [1]	2/34 (5.88%)	2
† Indicates events were collected by systematic assessment; [1] Headache post study injection

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Mohamad Allaf, MD
• Organization: Johns Hopkins University
• Phone: 410-502-7710
• EMail: mallaf@jhmi.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Meyer AR, Carducci MA, Denmeade SR, Markowski MC, Pomper MG, Pierorazio PM, Allaf ME, Rowe SP, Gorin MA. Improved identification of patients with oligometastatic clear cell renal cell carcinoma with PSMA-targeted (18)F-DCFPyL PET/CT. Ann Nucl Med. 2019 Aug;33(8):617-623. doi: 10.1007/s12149-019-01371-8. Epub 2019 May 30.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02687139
• Other Study ID Numbers: IRB00075596
• First Submitted: February 11, 2016
• First Posted: February 22, 2016
• Results First Submitted: April 17, 2020
• Results First Posted: April 29, 2020
• Last Update Posted: April 29, 2020