Trial Outcomes & Findings for PET/MR Characterization of Renal Cell Carcinomas (NCT NCT04271254)
NCT ID: NCT04271254
Last Updated: 2023-08-24
Results Overview
The correlation between Positron Emission Tomography (PET) activity distribution and tumor subtype composition will be assessed as the relation of PET activity estimates (in the form of fractional tumor volume over PET SUV threshold of 2.0) and the fraction of tumor cores classified as ccB subtype by transcriptome analysis. Ten core samples will be taken from each tumor at surgery time and will be examined with a panel of 34 genes found to distinguish ccA and ccB subtypes. The single subject's tissue analysis will not done immediately following surgery because the study was planned from the beginning to bank the tissue samples and analyze them all at once at the completion of the study.
TERMINATED
NA
5 participants
PET/MR scans will be taken within four weeks prior to surgery. Tissue samples will be taken at the time of surgery. (from the PET/MR scan to Surgery Day=Day 1)
2023-08-24
Participant Flow
Between 08/01/2020- 06/14/2023, 5 subjects consented and enrolled in the study at one center in North Carolina.
although 5 subjects signed the consent and enrolled in the study, 2 subjects underwent Positron Emission Tomography (PET) and magnetic resonance (MR) imaging and have available tissue specimens. The tumor type was not renal cell carcinoma in one out of 2 subjects with tissue specimens. Only 1 subject has an available tissue specimen.
Participant milestones
| Measure |
PET/MR
Each patient will undergo one combined PET/MR scan prior to surgery. The PET/MR scans are for research purposes and not part of the patient's standard of care.
PET/MR: The patient will be scheduled for a pre-surgery PET/MR within four weeks of the scheduled surgery.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
PET/MR
Each patient will undergo one combined PET/MR scan prior to surgery. The PET/MR scans are for research purposes and not part of the patient's standard of care.
PET/MR: The patient will be scheduled for a pre-surgery PET/MR within four weeks of the scheduled surgery.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
PET/MR Characterization of Renal Cell Carcinomas
Baseline characteristics by cohort
| Measure |
PET/MR
n=5 Participants
Each patient will undergo one combined PET/MR scan prior to surgery. The PET/MR scans are for research purposes and not part of the patient's standard of care.
PET/MR: Patient will be scheduled for a pre-surgery PET/MR within four weeks of scheduled surgery.
|
|---|---|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: PET/MR scans will be taken within four weeks prior to surgery. Tissue samples will be taken at the time of surgery. (from the PET/MR scan to Surgery Day=Day 1)Population: Data was not collected. The study was close to accrual before reaching target accrual because the internal funding source for the study recommended closure due to poor accrual. Only one subject meeting the study criteria completed the imaging portion of the study and has a tissue sample for transcriptome analysis. Transcript analysis was not performed for a single subject since the result of a single subject would not provide a conclusion.
The correlation between Positron Emission Tomography (PET) activity distribution and tumor subtype composition will be assessed as the relation of PET activity estimates (in the form of fractional tumor volume over PET SUV threshold of 2.0) and the fraction of tumor cores classified as ccB subtype by transcriptome analysis. Ten core samples will be taken from each tumor at surgery time and will be examined with a panel of 34 genes found to distinguish ccA and ccB subtypes. The single subject's tissue analysis will not done immediately following surgery because the study was planned from the beginning to bank the tissue samples and analyze them all at once at the completion of the study.
Outcome measures
Outcome data not reported
Adverse Events
PET/MR
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
David Lalush
University of North Carolina Lineberger Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place