An Early Phase 1 interventional study of Dynamic Contrast Enhanced Computed Tomography in Liver Cancer, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-05-02.
Sponsored by University of Colorado, Denver · Early Phase 1, Interventional, and Diagnostic
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.
1,406 studies on the registry are indexed under Liver Neoplasms; 347 are open to participants now.
This study's enrollment of 3 is below the median of 47 across 975 interventional studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 319 are open to participants now.
Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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.
Diagnostic Test: Dynamic 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.
Also known as: DCE-CT, Perfusion CT
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to end of follow-up, up to 12 weeks
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
Time frame: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and K-Trans: Sex
Stratify K-Trans results by sex to determine correlation of DCE-CT imaging results compared to patient demographics
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Post follow-up to end of study, up to 12 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Aug 2019 to primary completion in Dec 2021, 28 months.
Of 47 non-industry phase 1 interventional studies under Liver Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 77. This study's 28 months is below that.
Counting every sponsor, half of 79 studies reached it within 52 months; a quarter within 36 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver →