Trial Outcomes & Findings for Comparison of Yttrium-90 Absorbed Doses Using PET/CT Versus PET/MR Imaging for Hepatic Malignancies (NCT NCT04332419)
NCT ID: NCT04332419
Last Updated: 2022-06-22
Results Overview
RDC between the two imaging modalities for post-Y-90 Radioembolization (RE) absorbed doses (Gy) in the liver tumor tissues The RDC is the minimum difference between the two measurements that can be considered a true difference, with 95% confidence.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Post-op day 0, 1 hour apart
Results posted on
2022-06-22
Participant Flow
Participant milestones
| Measure |
PET/CT & PET/MR
One-time PET/MR imaging in addition to the standard PET/CT imaging, both performed on the same day of the treatment procedure (Selective Internal Radiation Therapy Y-90 RE). Participants will be randomized to receive either of the imaging modalities first, based on the availability of the imaging device, and less than 1 hour apart.
PET/CT: Standard Imaging
PET/MR: Additional Imaging
SIRT with Y-90: SIRT with Y-90 for palliative treatment of the liver malignancy.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
PET/CT & PET/MR
One-time PET/MR imaging in addition to the standard PET/CT imaging, both performed on the same day of the treatment procedure (Selective Internal Radiation Therapy Y-90 RE). Participants will be randomized to receive either of the imaging modalities first, based on the availability of the imaging device, and less than 1 hour apart.
PET/CT: Standard Imaging
PET/MR: Additional Imaging
SIRT with Y-90: SIRT with Y-90 for palliative treatment of the liver malignancy.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Comparison of Yttrium-90 Absorbed Doses Using PET/CT Versus PET/MR Imaging for Hepatic Malignancies
Baseline characteristics by cohort
| Measure |
PET/CT & PET/MR
n=11 Participants
One-time PET/MR imaging in addition to the standard PET/CT imaging, both performed on the same day of the treatment procedure (Selective Internal Radiation Therapy Y-90 RE). Participants will be randomized to receive either of the imaging modalities first, based on the availability of the imaging device, and less than 1 hour apart.
PET/CT: Standard Imaging
PET/MR: Additional Imaging
SIRT with Y-90: SIRT with Y-90 for palliative treatment of the liver malignancy.
|
|---|---|
|
Age, Continuous
|
67.8 Years
STANDARD_DEVIATION 10.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Post-op day 0, 1 hour apartRDC between the two imaging modalities for post-Y-90 Radioembolization (RE) absorbed doses (Gy) in the liver tumor tissues The RDC is the minimum difference between the two measurements that can be considered a true difference, with 95% confidence.
Outcome measures
| Measure |
PET/CT & PET/MR
n=17 Tumors
One-time PET/MR imaging in addition to the standard PET/CT imaging, both performed on the same day of the treatment procedure (Selective Internal Radiation Therapy Y-90 RE). Participants will be randomized to receive either of the imaging modalities first, based on the availability of the imaging device, and less than 1 hour apart.
PET/CT: Standard Imaging
PET/MR: Additional Imaging
SIRT with Y-90: SIRT with Y-90 for palliative treatment of the liver malignancy.
|
|---|---|
|
Reproducibility Coefficient (RDC) Between the Two Imaging Modalities in Liver Tumor Tissues
|
16.9 percent difference
Interval 12.7 to 25.3
|
SECONDARY outcome
Timeframe: Post-op day 0, 1 hour apartRDC between the two imaging modalities for post-Y-90 RE absorbed doses (Gy) in the background liver tissues The RDC is the minimum difference between the two measurements that can be considered a true difference, with 95% confidence.
Outcome measures
| Measure |
PET/CT & PET/MR
n=17 sessions
One-time PET/MR imaging in addition to the standard PET/CT imaging, both performed on the same day of the treatment procedure (Selective Internal Radiation Therapy Y-90 RE). Participants will be randomized to receive either of the imaging modalities first, based on the availability of the imaging device, and less than 1 hour apart.
PET/CT: Standard Imaging
PET/MR: Additional Imaging
SIRT with Y-90: SIRT with Y-90 for palliative treatment of the liver malignancy.
|
|---|---|
|
RDC Between the Two Imaging Modalities in Background Liver Tissues
|
25.8 percent difference
Interval 18.5 to 42.5
|
Adverse Events
PET/CT & PET/MR
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. Ram Gurajala, MD
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Phone: 1-866-223-8100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place