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

NCT ID: NCT03891654

Last Updated: 2022-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2022-04-28

Brief Summary

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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

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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.

Conditions

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Liver Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dynamic Contrast Enhanced Computed Tomography

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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DCE-CT Perfusion CT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moyed Miften, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Denver

Aurora, Colorado, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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P30CA046934

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-2874.cc

Identifier Type: -

Identifier Source: org_study_id

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