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

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 18F-DCFPyL PET/CT
Hide 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
Arm/Group Title 18F-DCFPyL PET/CT
Hide 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
Hide 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%
1.Primary Outcome
Title Number of Participants With 18F-DCFPyL PET/CT Detected Sites of Metastatic Renal Cell Carcinoma (RCC)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 18F-DCFPyL PET/CT
Hide 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
Hide Description This was assessed to Correlate Sites of Radiotracer Uptake on 18F-DCFPyL PET/CT With Conventional Imaging Findings.
Time Frame 12 Months
Hide Outcome Measure Data
Hide 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
Hide 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%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 18F-DCFPyL PET/CT
Hide 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%)    
Hide Serious Adverse Events
18F-DCFPyL PET/CT
Affected / at Risk (%) # Events
Total   0/34 (0.00%)    
Hide 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
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mohamad Allaf, MD
Organization: Johns Hopkins University
Phone: 410-502-7710
EMail: mallaf@jhmi.edu
Layout table for additonal information
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