Kidney Cancer, Renal Cell Carcinoma
Conditions
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).
Interventions
DRUG18F-DCFPyL
PROCEDUREPET/CT
Positron Emission Tomography - Computed Tomography (PET/CT)
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 18F-DCFPyL PET/CT Men and women of all races and ethnic groups are eligible for this study were encouraged to participate. | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | 18F-DCFPyL PET/CT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 60 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment United States | 34 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 3 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Number of Participants With 18F-DCFPyL PET/CT Detected Sites of Metastatic Renal Cell Carcinoma (RCC)
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 18F-DCFPyL PET/CT | Number of Participants With 18F-DCFPyL PET/CT Detected Sites of Metastatic Renal Cell Carcinoma (RCC) | 34 Participants |
Primary
Number of Participants With a Correlation Between Radiotracer Uptake on 18F-DCFPyL PET/CT and Conventional Imaging
This was assessed to Correlate Sites of Radiotracer Uptake on 18F-DCFPyL PET/CT With Conventional Imaging Findings.
Time frame: 12 Months
Population: Only the first 14 participants enrolled in this study were assessed for this outcome and published at the time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 18F-DCFPyL PET/CT | Number of Participants With a Correlation Between Radiotracer Uptake on 18F-DCFPyL PET/CT and Conventional Imaging | 4 Participants |