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

Early Phase 1

Completed

• Conditions: Liver Cancer
• Interventions: Diagnostic Test: Dynamic Contrast Enhanced Computed Tomography

• Registration Number: NCT03891654
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-27
• Study Start: 2019-08-01
• Primary Completion: 2021-12-20
• Status Verified: 2022-04
• Study Completion: 2022-04-28
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dynamic Contrast Enhanced Computed Tomography	Dynamic Contrast Enhanced Computed Tomography	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.

Primary Outcome Measures

Name	Time	Method
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: 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 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 Outcome Measures

Name	Time	Method
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 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 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: 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 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 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
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: 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 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: 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 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 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

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States