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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03891654
• Other study ID #: 18-2874.cc
• Secondary ID: P30CA046934
• Status: Completed
• Phase: Early Phase 1
• Start date: August 1, 2019
• Est. completion date: April 28, 2022

Study information

• Verified date: April 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: April 28, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to end of follow-up, up to 12 weeks
Primary	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.	Baseline to end of follow-up, up to 12 weeks
Primary	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.	Baseline to end of follow-up, up to 12 weeks
Secondary	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	Post follow-up to end of study, up to 12 months
Secondary	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	Post follow-up to end of study, up to 12 months
Secondary	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	Post follow-up to end of study, up to 12 months
Secondary	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	Post follow-up to end of study, up to 12 months
Secondary	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	Post follow-up to end of study, up to 12 months
Secondary	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	Post follow-up to end of study, up to 12 months
Secondary	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	Post follow-up to end of study, up to 12 months
Secondary	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	Post follow-up to end of study, up to 12 months
Secondary	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	Post follow-up to end of study, up to 12 months
Secondary	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	Post follow-up to end of study, up to 12 months
Secondary	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	Post follow-up to end of study, up to 12 months
Secondary	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	Post follow-up to end of study, up to 12 months