Evaluation of Atherosclerotic Plaques in Abdominal CT Studies

NCT04652973 | Active Not Recruiting

• 2 other identifiers: 10000123000123-CC
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms

Keywords

CT measurement; CVD; CT coronary angiogram; clinical biomarkers; Natural History

Outcome Measures

Primary Outcomes (1)

• 1/Measure atherosclerotic plaques

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

  End of study

Secondary Outcomes (1)

• 2/Plaque measurement and clinical biomarkers correlation

  End of study

Study Arms (2)

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.

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Two separate study populations were recruited. The "Prostate cancer dataset" consisted of biopsy-proven prostate cancer patients who have abdomen CT studies that were available in the clinical PACS (picture archiving system) in the Clinical Center. Men of all ages and races are included. The "Multiphase CT dataset" consisted of men or women of all age and race, who have Multiphase abdomen-pelvic CT studies that were available in the PACS.

You may qualify if:

• The study will use existing radiologic data.

You may not qualify if:

• NONE

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ronald M Summers, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 4, 2020
• Study Start: November 19, 2020
• Primary Completion (Estimated): August 30, 2030
• Study Completion (Estimated): August 30, 2030
• Last Updated: September 30, 2026

Record last verified: 2026-09-28

Locations

US (1)