Dynamic Contrast Enhanced Computed Tomography to Assess Radiation Therapy in Liver Cancer Patients

Early Phase 1CompletedNCT03891654

University of Colorado, Denver3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Liver Cancer

Interventions

Dynamic Contrast Enhanced Computed TomographyDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Colorado Denver

Aurora, Colorado, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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