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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET/CT & PET/MR | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/CT | Device | Standard Imaging |
| |
| PET/MR |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-op day 0, 1 hour apart |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-op day 0, 1 hour apart |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ram Gurajala, MD | Cleveland Clinic, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic, Case Comprehensive Cancer Center | Cleveland | Ohio | 44122 | United States |
Team will be sharing study results but not IPD because of HIPAA regulations
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | percent difference | Post-op day 0, 1 hour apart | Tumors | Tumors |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ram Gurajala, MD | Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center | 1-866-223-8100 | TaussigResearch@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2021 | Jun 1, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 3, 2020 | Sep 1, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| D037761 | Sirtuins |
| C000615496 | Yttrium-90 |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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| Device |
Additional Imaging |
|
| SIRT with Y-90 | Radiation | SIRT with Y-90 for palliative treatment of the liver malignancy. |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | percent difference | Post-op day 0, 1 hour apart | sessions | sessions |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
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| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
| D056545 | Group III Histone Deacetylases |
| D006655 | Histone Deacetylases |
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D036002 | ADP Ribose Transferases |
| D010430 | Pentosyltransferases |
| D016695 | Glycosyltransferases |
| D014166 | Transferases |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |