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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891654
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Liver Cancer Diagnostic Test: Dynamic Contrast Enhanced Computed Tomography Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Pilot Study of Dynamic Contrast Enhanced Computed Tomography (DCE-CT) Imaging for the Assessment of Radiation Therapy Outcome for Liver Cancer Patients
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891654


Contacts
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Contact: Tess Santangelo 720-848-9398 tess.santangelo@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Tess Santangelo    720-848-9398    tess.santangelo@ucdenver.edu   
Principal Investigator: Moyed Miften, PhD         
Sponsors and Collaborators
University of Colorado, Denver
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Moyed Miften, PhD University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03891654    
Other Study ID Numbers: 18-2874.cc
P30CA046934 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Colorado, Denver:
Radiation
Metastases
Dynamic Contrast Enhanced Computed Tomography
Pilot
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases