Trial Outcomes & Findings for Non-Contrast Perfusion Using Arterial Spin Labeled MR Imaging for Assessment of Therapy Response in Metastatic Renal Cell Carcinoma (NCT NCT04831138)
NCT ID: NCT04831138
Last Updated: 2025-12-19
Results Overview
Measure change in perfusion at 7 days and 14 days compared to baseline measurement.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
Baseline to 7 and 14 days
Results posted on
2025-12-19
Participant Flow
Participant milestones
| Measure |
Renal Cell Carcinoma (RCC) Patients
Patients with locally advanced or metastatic renal cell carcinoma
Magnetic Resonance Imaging (MRI) with Arterial Spin Labeling (ASL): T0 (Week 0): MRI with ASL will be performed either for research alone or along with patient's standard of care imaging session including contrast-enhancement.
T1 (Day 7+-2): contrast-enhanced research MRI with ASL T2 (Day 14+-2): contrast-enhanced research MRI with ASL T3: MRI with ASL will be performed along with patient's standard of care imaging session.
T4: MRI with ASL will be performed along with patient's standard of care imaging session.
T5: MRI with ASL will be performed along with patient's standard of care imaging session.
|
Healthy Volunteers
Healthy volunteers to optimize protocol
ASL-MRI: Healthy volunteers - MRI with ASL protocol optimization
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
|
Overall Study
COMPLETED
|
0
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Renal Cell Carcinoma (RCC) Patients
Patients with locally advanced or metastatic renal cell carcinoma
Magnetic Resonance Imaging (MRI) with Arterial Spin Labeling (ASL): T0 (Week 0): MRI with ASL will be performed either for research alone or along with patient's standard of care imaging session including contrast-enhancement.
T1 (Day 7+-2): contrast-enhanced research MRI with ASL T2 (Day 14+-2): contrast-enhanced research MRI with ASL T3: MRI with ASL will be performed along with patient's standard of care imaging session.
T4: MRI with ASL will be performed along with patient's standard of care imaging session.
T5: MRI with ASL will be performed along with patient's standard of care imaging session.
|
Healthy Volunteers
Healthy volunteers to optimize protocol
ASL-MRI: Healthy volunteers - MRI with ASL protocol optimization
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Non-Contrast Perfusion Using Arterial Spin Labeled MR Imaging for Assessment of Therapy Response in Metastatic Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
RCC Patients
n=2 Participants
Patients with locally advanced or metastatic renal cell carcinoma
MRI with ASL: T0 (Week 0): MRI with ASL will be performed either for research alone or along with patient's standard of care imaging session including contrast-enhancement.
T1 (Day 7+-2): contrast-enhanced research MRI with ASL T2 (Day 14+-2): contrast-enhanced research MRI with ASL T3: MRI with ASL will be performed along with patient's standard of care imaging session.
T4: MRI with ASL will be performed along with patient's standard of care imaging session.
T5: MRI with ASL will be performed along with patient's standard of care imaging session.
|
Healthy Volunteers
n=4 Participants
Healthy volunteers to optimize protocol
ASL-MRI: Healthy volunteers - MRI with ASL protocol optimization
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=8 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=8 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=8 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=8 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=8 Participants
|
4 participants
n=6 Participants
|
6 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline to 7 and 14 daysPopulation: Data were not collected and analyzed due to termination of the study and the 2 RCC patients enrolled not completing the study.
Measure change in perfusion at 7 days and 14 days compared to baseline measurement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 2 weeksMeasurement of perfusion in kidneys in healthy volunteers for the assessment of repeatability.
Outcome measures
| Measure |
RCC Patients
n=4 Participants
Patients with locally advanced or metastatic renal cell carcinoma
MRI with ASL: T0 (Week 0): MRI with ASL will be performed either for research alone or along with patient's standard of care imaging session including contrast-enhancement.
T1 (Day 7+-2): contrast-enhanced research MRI with ASL
|
|---|---|
|
Repeatability of Perfusion Measurement in Kidneys
Baseline
|
306 ml/100g/min
Standard Deviation 60
|
|
Repeatability of Perfusion Measurement in Kidneys
2 weeks
|
283 ml/100g/min
Standard Deviation 56
|
Adverse Events
RCC Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Volunteers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ananth Madhuranthakam
UT Southwestern Medical Center
Phone: 214-648-7737
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place