Clinical trial NCT03891654: Dynamic Contrast Enhanced Computed Tomography to Assess Radiation Therapy in Liver Cancer Patients
Official title: Pilot Study of Dynamic Contrast Enhanced Computed Tomography (DCE-CT) Imaging for the Assessment of Radiation Therapy Outcome for Liver Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Liver Cancer
Keywords: Radiation
Metastases
Dynamic Contrast Enhanced Computed Tomography
Pilot
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-03-27
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each patient will receive the standard of care, with the intervention, DCE-CT perfusion, occurring pre-treatment and post-treatment
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: DCE-CT Perfusion Metrics: K-Trans
timeFrame: Baseline to end of follow-up, up to 12 weeks
measure: DCE-CT Perfusion Metrics: Blood Volume
timeFrame: Baseline to end of follow-up, up to 12 weeks
measure: DCE-CT Perfusion Metrics: Blood Flow
timeFrame: Baseline to end of follow-up, up to 12 weeks
Secondary outcomes:
measure: Correlation Between Patient Demographics and K-Trans: Age
timeFrame: Post follow-up to end of study, up to 12 months
measure: Correlation Between Patient Demographics and K-Trans: Sex
timeFrame: Post follow-up to end of study, up to 12 months
measure: Correlation Between Patient Demographics and K-Trans: Race
timeFrame: Post follow-up to end of study, up to 12 months
measure: Correlation Between Patient Demographics and K-Trans: Clinical Stage of Disease
timeFrame: Post follow-up to end of study, up to 12 months
measure: Correlation Between Patient Demographics and Blood Volume: Age
timeFrame: Post follow-up to end of study, up to 12 months
measure: Correlation Between Patient Demographics and Blood Volume: Sex
timeFrame: Post follow-up to end of study, up to 12 months
measure: Correlation Between Patient Demographics and Blood Volume: Race
timeFrame: Post follow-up to end of study, up to 12 months
measure: Correlation Between Patient Demographics and Blood Volume: Clinical Stage of Disease
timeFrame: Post follow-up to end of study, up to 12 months
measure: Correlation Between Patient Demographics and Blood Flow: Age
timeFrame: Post follow-up to end of study, up to 12 months
measure: Correlation Between Patient Demographics and Blood Flow: Sex
timeFrame: Post follow-up to end of study, up to 12 months
measure: Correlation Between Patient Demographics and Blood Flow: Race
timeFrame: Post follow-up to end of study, up to 12 months
measure: Correlation Between Patient Demographics and Blood Flow: Clinical Stage of Disease
timeFrame: Post follow-up to end of study, up to 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Moyed Miften, PhD
role: PRINCIPAL_INVESTIGATOR
References: