Evaluation of Atherosclerotic Plaques in Abdominal CT Studies

Sponsor
National Institutes of Health Clinical Center (CC) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT04652973
Collaborator
(none)
1,000
Enrollment
1
Location
117.3
Anticipated Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:

Fat and calcium can build up as plaque in artery walls. The Agatston score measures plaque using computed tomography (CT) that does not use an injected contrast agent. Plaque in the arteries of the pelvis and abdomen is linked to cardiovascular disease (CVD) risk factors. It also may affect cancer. But abdominal CTs use a contrast agent (CECT). Therefore, the Agatston score cannot be used. Researchers want to find a way to measure plaque in CECTs. This will help them use abdominal CTs to measure plaque without extra radiation.

Objective:

To measure atherosclerotic plaques on CECT in a group of males.

Eligibility:

Men ages 30-90 with prostate cancer (proven with biopsies) who have abdomen CT studies in the PACS (picture archiving system) in the Clinical Center. Also, men or women of all ages who have multiphase abdomen and pelvic CT studies that are in the PACS.

Design:

This study will use data gathered since 1/1/2013. Data will also be taken from protocol 03-CC-0128 and clinical trials 15-C-0124, 16-C-0048, 14-C-0112, and 04-C-0274. Participants from these studies have allowed their samples to be used in the future.

Participants will be found via keyword searches on NIH databases. Their CT and MRI scans will be used. Data such as age, race, disease, and treatment will be used. Results of other tests may be used.

The plaque in participants abdomen and iliac arteries will be measured. It will be compared with biomarkers related to CVD and prostate cancer, such as weight, age, and race.

This study will take place at one site. Data will be stored on secure computers. Printouts will be kept in locked rooms.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    Evaluation of Atherosclerotic Plaques in Prostate Cancer Patients.

    Study Description:

    This study measures atherosclerotic plaques in the vessels of prostate cancer patients in contrast-enhanced computed tomography (CECT), then finds correlation between the plaque and clinical biomarkers. These biomarkers include laboratory tests, pathologic findings, underlying risk factors, demographic information, and outcomes of the patient.

    Objectives:

    Primary objective: Measure atherosclerotic plaques on contrast-enhanced computed tomography (CECT).

    Secondary objective: Find correlation between plaque measurement and clinical biomarkers of prostate cancer patients.

    Study Population:

    Up to 1,000 NIH Clinical Center patients.

    Description of Sites/Facilities conducting research:

    NIH Clinical Center

    Study Duration:

    10 years

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1000 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Evaluation of Atherosclerotic Plaques in Abdominal CT Studies
    Actual Study Start Date :
    Nov 19, 2020
    Anticipated Primary Completion Date :
    Aug 30, 2030
    Anticipated Study Completion Date :
    Aug 30, 2030

    Arms and Interventions

    ArmIntervention/Treatment
    1/Prostate cancer dataset

    Biopsy-proven prostate cancer patients who have abdomen CT studies that were available in the clinical PACS (picture archiving system) in the Clinical Center.

    2/Multiphase CT dataset

    Men or women of all age and race, who have Multiphase abdomen-pelvic CT studies that were available in the PACS.

    Outcome Measures

    Primary Outcome Measures

    1. 1/Measure atherosclerotic plaques [End of study]

      Measure atherosclerotic plaques on contrast-enhanced computed tomography (CECT)

    Secondary Outcome Measures

    1. 2/Plaque measurement and clinical biomarkers correlation [End of study]

      Find correlation between plaque measurement and clinical biomarkers of prostate cancer patients.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • INCLUSION CRITERIA:

    The study will use existing radiologic data.

    EXCLUSION CRITERIA:

    NONE

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1National Institutes of Health Clinical CenterBethesdaMarylandUnited States20892

    Sponsors and Collaborators

    • National Institutes of Health Clinical Center (CC)

    Investigators

    • Principal Investigator: Ronald M Summers, M.D., National Institutes of Health Clinical Center (CC)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Institutes of Health Clinical Center (CC)
    ClinicalTrials.gov Identifier:
    NCT04652973
    Other Study ID Numbers:
    • 10000123
    • 000123-CC
    First Posted:
    Dec 4, 2020
    Last Update Posted:
    Oct 11, 2021
    Last Verified:
    Oct 7, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institutes of Health Clinical Center (CC)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 11, 2021