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NCT Number: NCT03891654

Dynamic Contrast Enhanced Computed Tomography to Assess Radiation Therapy in 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.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dynamic Contrast Enhanced Computed Tomography

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.

Other names: DCE-CT, Perfusion CT

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Mar 27, 2019
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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