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

Primary Purpose

Liver Cancer

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Dynamic Contrast Enhanced Computed Tomography

About this trial

This is an interventional diagnostic trial for Liver Cancer focused on measuring Radiation, Metastases, Dynamic Contrast Enhanced Computed Tomography, Pilot

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provision to sign and date the consent form
Stated willingness to comply with all study procedures and be available for the duration of the study
Be a Male or Female aged 18-100
Diagnosed with Liver HCC or metastases
Must be receiving or will plan to receive SBRT for Liver HCC or metastases

Exclusion Criteria:

Allergy to iodine contrast
CT with contrast not offered as a Standard of Care
Pregnant women

Sites / Locations

University of Colorado Denver

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dynamic Contrast Enhanced Computed Tomography

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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

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

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

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

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

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

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

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

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

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

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

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

Full Information

NCT ID

NCT03891654

First Posted

March 25, 2019

Last Updated

April 28, 2022

Sponsor

University of Colorado, Denver

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03891654

Brief Title

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

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

December 20, 2021 (Actual)

Study Completion Date

April 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cancer

Keywords

Radiation, Metastases, Dynamic Contrast Enhanced Computed Tomography, Pilot

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Each patient will receive the standard of care, with the intervention, DCE-CT perfusion, occurring pre-treatment and post-treatment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dynamic Contrast Enhanced Computed Tomography

Arm Type

Experimental

Arm Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Dynamic Contrast Enhanced Computed Tomography

Other Intervention Name(s)

DCE-CT, Perfusion CT

Intervention Description

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.

Primary Outcome Measure Information:

Title

DCE-CT Perfusion Metrics: K-Trans

Description

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

Title

DCE-CT Perfusion Metrics: Blood Volume

Description

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

Title

DCE-CT Perfusion Metrics: Blood Flow

Description

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 Outcome Measure Information:

Title

Correlation Between Patient Demographics and K-Trans: Age

Description

Stratify K-Trans results by age to determine correlation of DCE-CT imaging results compared to patient demographics

Time Frame