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

April 28, 2022 updated by: University of Colorado, Denver

Pilot Study of Dynamic Contrast Enhanced Computed Tomography (DCE-CT) Imaging for the Assessment of Radiation Therapy Outcome for Liver Cancer Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • DCE-CT
  • Perfusion CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DCE-CT Perfusion Metrics: K-Trans
Time Frame: 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.
Baseline to end of follow-up, up to 12 weeks
DCE-CT Perfusion Metrics: Blood Volume
Time Frame: 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.
Baseline to end of follow-up, up to 12 weeks
DCE-CT Perfusion Metrics: Blood Flow
Time Frame: 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.
Baseline to end of follow-up, up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between Patient Demographics and K-Trans: Age
Time Frame: 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
Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and K-Trans: Sex
Time Frame: 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
Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and K-Trans: Race
Time Frame: 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
Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and K-Trans: Clinical Stage of Disease
Time Frame: 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
Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Volume: Age
Time Frame: 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
Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Volume: Sex
Time Frame: 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
Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Volume: Race
Time Frame: 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
Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Volume: Clinical Stage of Disease
Time Frame: 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
Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Flow: Age
Time Frame: 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
Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Flow: Sex
Time Frame: 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
Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Flow: Race
Time Frame: 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
Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Flow: Clinical Stage of Disease
Time Frame: 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
Post follow-up to end of study, up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Moyed Miften, PhD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

December 20, 2021

Study Completion (Actual)

April 28, 2022

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-2874.cc
  • P30CA046934 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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