Hepatic Malignancies
Conditions
Brief summary
The purpose of this study is to compare the results of positron emission tomography/computer tomography (PET/CT) to positron emission tomography/magnetic resonance imaging (PET/MRI) to help determine any added advantage of one over the other in relation to a tumor which might assist in further management plans.
Detailed description
Participants in this study will undergo PET/CT (standard imaging) and PET/MR (additional imaging), within 6 hours after SIRT with Y-90 for palliative treatment of the liver malignancy. Patients 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. Upon acquirement and construction of PET/CT and PET/MR images, a software (MIM SurePlan LiverY90) would be utilized for semi-automatic determination of the liver/tumor contours and calculation of the Y-90 absorbed doses (Gy) in the regions of interest (including within tumor and background liver outlines) using the Local Deposition Method. The primary objective of this study is to assess the agreement between post-Y-90 RE absorbed doses (Gy) in the liver tumor tissues based on PET/CT versus PET/MR imaging. This would permit the comparison of Y-90 tumor absorbed doses, acquired from PET/MR, with the current standard of care PET/CT imaging to verify the data consistency and to validate its application for the prediction of tumor response to treatment. The secondary objective of this study is to assess the agreement between post-Y-90 RE absorbed doses (Gy) in the background liver tissues (surrounding tumors), based on PET/CT versus PET/MR imaging. This would permit the comparison of Y-90 background liver absorbed doses, acquired from PET/MR, with the current standard of care PET/CT imaging to verify the data consistency and to validate its application for the prediction of dose toxicity.
Interventions
DEVICEPET/CT
Standard Imaging
DEVICEPET/MR
Additional Imaging
RADIATIONSIRT with Y-90
SIRT with Y-90 for palliative treatment of the liver malignancy.
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient has a liver malignancy and is scheduled for SIRT with Y-90; AND * The patient is an adult, self-competent, and able to provide informed consent to participate in the study
Exclusion criteria
* The patient loses competence, has a condition that questions their ability to provide informed consent independently (e.g. cannot communicate in English), or withdraws consent to participate within any time in the study period; OR * The patient is not eligible to undergo MRI due to the presence of metal devices or implants in their body; OR * Both imaging modalities cannot take place within 6 hours after Y-90 RE; OR * Both imaging modalities cannot take place within 1 hour apart from each other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility Coefficient (RDC) Between the Two Imaging Modalities in Liver Tumor Tissues | Post-op day 0, 1 hour apart | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RDC Between the Two Imaging Modalities in Background Liver Tissues | Post-op day 0, 1 hour apart | RDC 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | PET/CT & PET/MR |
|---|---|
| Age, Continuous | 67.8 Years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Reproducibility Coefficient (RDC) Between the Two Imaging Modalities in Liver Tumor Tissues
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.
Time frame: Post-op day 0, 1 hour apart
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PET/CT & PET/MR | Reproducibility Coefficient (RDC) Between the Two Imaging Modalities in Liver Tumor Tissues | 16.9 percent difference |
Secondary
RDC Between the Two Imaging Modalities in Background Liver Tissues
RDC 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.
Time frame: Post-op day 0, 1 hour apart
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PET/CT & PET/MR | RDC Between the Two Imaging Modalities in Background Liver Tissues | 25.8 percent difference |