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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA046934 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This is a pilot study that uses a standard of care technique, Stereotactic Body Radiation Therapy (SBRT), in combination with Dynamic Contrast Enhanced Computed Tomography (DCE-CT) to determine if perfusion changes from SBRT of liver cancer may be used for outcome assessment and prediction of prognosis.
Patients will undergo standard of care SBRT while also receiving DCE-CT, also known as perfusion CT, pre-treatment, 6 hours post-treatment and 6 weeks post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic Contrast Enhanced Computed Tomography | Experimental | DCE-CT, also known as perfusion CT, is a functional imaging modality that uses repeated computed tomography imaging after injection of an iodine based contrast agent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Contrast Enhanced Computed Tomography | Diagnostic Test | Patients will receive DCE-CT prior to the start of standard of care, Stereotactic Body Radiation Therapy (SBRT), as well as 6 hours post administration of SBRT and 6 weeks post administration of SBRT. |
| Measure | Description | Time Frame |
|---|---|---|
| DCE-CT Perfusion Metrics: K-Trans | Determine the association between the delivered radiation therapy dose distribution and the change in perfusion measurement through K-Trans (extraction-flow product) as shown through DCE-CT imaging. | Baseline to end of follow-up, up to 12 weeks |
| DCE-CT Perfusion Metrics: Blood Volume | Determine the association between the delivered radiation therapy dose distribution and the change in perfusion measurement through blood volume as shown through DCE-CT imaging. | Baseline to end of follow-up, up to 12 weeks |
| DCE-CT Perfusion Metrics: Blood Flow | Determine the association between the delivered radiation therapy dose distribution and the change in perfusion measurement through blood flow as shown through DCE-CT imaging. | Baseline to end of follow-up, up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Patient Demographics and K-Trans: Age | Stratify K-Trans results by age to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months |
| Correlation Between Patient Demographics and K-Trans: Sex |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moyed Miften, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 16, 2020 | Jan 25, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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Each patient will receive the standard of care, with the intervention, DCE-CT perfusion, occurring pre-treatment and post-treatment
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|
Stratify K-Trans results by sex to determine correlation of DCE-CT imaging results compared to patient demographics |
| Post follow-up to end of study, up to 12 months |
| Correlation Between Patient Demographics and K-Trans: Race | Stratify K-Trans results by race to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months |
| Correlation Between Patient Demographics and K-Trans: Clinical Stage of Disease | Stratify K-Trans results by clinical stage at diagnosis to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months |
| Correlation Between Patient Demographics and Blood Volume: Age | Stratify blood volume results age to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months |
| Correlation Between Patient Demographics and Blood Volume: Sex | Stratify blood volume results sex to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months |
| Correlation Between Patient Demographics and Blood Volume: Race | Stratify blood volume results race to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months |
| Correlation Between Patient Demographics and Blood Volume: Clinical Stage of Disease | Stratify blood volume results by clinical stage at diagnosis to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months |
| Correlation Between Patient Demographics and Blood Flow: Age | Stratify blood flow results age to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months |
| Correlation Between Patient Demographics and Blood Flow: Sex | Stratify blood flow results sex to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months |
| Correlation Between Patient Demographics and Blood Flow: Race | Stratify blood flow results race to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months |
| Correlation Between Patient Demographics and Blood Flow: Clinical Stage of Disease | Stratify blood flow results by clinical stage at diagnosis to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months |
| D008107 |
| Liver Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |