Study of PSMA-targeted 18F-DCFPyL PET/CT in the Evaluation of Patients With Renal Cell Carcinoma
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 18F-DCFPyL PET/CT
|
Drug: 18F-DCFPyL
Procedure: PET/CT
Positron Emission Tomography - Computed Tomography (PET/CT)
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With 18F-DCFPyL PET/CT Detected Sites of Metastatic Renal Cell Carcinoma (RCC) [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.
- Number of Participants With a Correlation Between Radiotracer Uptake on 18F-DCFPyL PET/CT and Conventional Imaging [12 Months]
This was assessed to Correlate Sites of Radiotracer Uptake on 18F-DCFPyL PET/CT With Conventional Imaging Findings.
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins Hospital | Baltimore | Maryland | United States | 21287 |
Sponsors and Collaborators
- Johns Hopkins University
Investigators
- Principal Investigator: Mohamad Allaf, MD, Johns Hopkins University
Study Documents (Full-Text)
More Information
Publications
None provided.- IRB00075596
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| 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 Participants | 34 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
9
26.5%
|
| >=65 years |
25
73.5%
|
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
60
|
| Sex: Female, Male (Count of Participants) | |
| Female |
10
29.4%
|
| Male |
24
70.6%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
1
2.9%
|
| Not Hispanic or Latino |
31
91.2%
|
| Unknown or Not Reported |
2
5.9%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
1
2.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
31
91.2%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
2
5.9%
|
| Region of Enrollment (Count of Participants) | |
| United States |
34
100%
|
Outcome Measures
| 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) |
| Measure Participants | 34 |
| Count of Participants [Participants] |
34
100%
|
| 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) |
| Measure Participants | 14 |
| Count of Participants [Participants] |
4
11.8%
|
Adverse Events
| Time Frame | 1 year | |
|---|---|---|
| Adverse Event Reporting Description | ||
| 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 (%) | # Events | |
| Total | 0/34 (0%) | |
Serious Adverse Events |
||
| 18F-DCFPyL PET/CT | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/34 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| 18F-DCFPyL PET/CT | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/34 (8.8%) | |
| Gastrointestinal disorders | ||
| Constipation | 1/34 (2.9%) | 1 |
| Nausea | 1/34 (2.9%) | 1 |
| Nervous system disorders | ||
| Headache | 2/34 (5.9%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Mohamad Allaf, MD |
|---|---|
| Organization | Johns Hopkins University |
| Phone | 410-502-7710 |
| mallaf@jhmi.edu |
- IRB00075596