Liver Cancer
Conditions
Keywords
Radiation, Metastases, Dynamic Contrast Enhanced Computed Tomography, Pilot
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTDynamic Contrast Enhanced Computed Tomography
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.
Sponsors
National Cancer Institute (NCI)
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Each patient will receive the standard of care, with the intervention, DCE-CT perfusion, occurring pre-treatment and post-treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Provision to sign and date the consent form 2. Stated willingness to comply with all study procedures and be available for the duration of the study 3. Be a Male or Female aged 18-100 4. Diagnosed with Liver HCC or metastases 5. Must be receiving or will plan to receive SBRT for Liver HCC or metastases
Exclusion criteria
1. Allergy to iodine contrast 2. CT with contrast not offered as a Standard of Care 3. Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DCE-CT Perfusion Metrics: K-Trans | Baseline to end of follow-up, up to 12 weeks | 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. |
| DCE-CT Perfusion Metrics: Blood Volume | Baseline to end of follow-up, up to 12 weeks | 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. |
| DCE-CT Perfusion Metrics: Blood Flow | Baseline to end of follow-up, up to 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Patient Demographics and K-Trans: Clinical Stage of Disease | Post follow-up to end of study, up to 12 months | Stratify K-Trans results by clinical stage at diagnosis to determine correlation of DCE-CT imaging results compared to patient demographics |
| Correlation Between Patient Demographics and Blood Volume: Age | Post follow-up to end of study, up to 12 months | Stratify blood volume results age to determine correlation of DCE-CT imaging results compared to patient demographics |
| Correlation Between Patient Demographics and Blood Volume: Sex | Post follow-up to end of study, up to 12 months | Stratify blood volume results sex to determine correlation of DCE-CT imaging results compared to patient demographics |
| Correlation Between Patient Demographics and Blood Volume: Race | Post follow-up to end of study, up to 12 months | Stratify blood volume results race to determine correlation of DCE-CT imaging results compared to patient demographics |
| Correlation Between Patient Demographics and K-Trans: Age | Post follow-up to end of study, up to 12 months | Stratify K-Trans results by age to determine correlation of DCE-CT imaging results compared to patient demographics |
| Correlation Between Patient Demographics and Blood Flow: Age | Post follow-up to end of study, up to 12 months | Stratify blood flow results age to determine correlation of DCE-CT imaging results compared to patient demographics |
| Correlation Between Patient Demographics and Blood Flow: Sex | Post follow-up to end of study, up to 12 months | Stratify blood flow results sex to determine correlation of DCE-CT imaging results compared to patient demographics |
| Correlation Between Patient Demographics and Blood Flow: Race | Post follow-up to end of study, up to 12 months | Stratify blood flow results race to determine correlation of DCE-CT imaging results compared to patient demographics |
| Correlation Between Patient Demographics and Blood Flow: Clinical Stage of Disease | Post follow-up to end of study, up to 12 months | Stratify blood flow results by clinical stage at diagnosis to determine correlation of DCE-CT imaging results compared to patient demographics |
| Correlation Between Patient Demographics and Blood Volume: Clinical Stage of Disease | Post follow-up to end of study, up to 12 months | Stratify blood volume results by clinical stage at diagnosis to determine correlation of DCE-CT imaging results compared to patient demographics |
| Correlation Between Patient Demographics and K-Trans: Sex | Post follow-up to end of study, up to 12 months | Stratify K-Trans results by sex to determine correlation of DCE-CT imaging results compared to patient demographics |
| Correlation Between Patient Demographics and K-Trans: Race | Post follow-up to end of study, up to 12 months | Stratify K-Trans results by race to determine correlation of DCE-CT imaging results compared to patient demographics |
Countries
United States
Outcome results
None listed