Evaluation of Atherosclerotic Plaques in Abdominal CT Studies

Prostatic Neoplasms Clinical Trial

Official title:

Evaluation of Atherosclerotic Plaques in Abdominal CT Studies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04652973
• Other study ID #: 10000123
• Secondary ID: 000123-CC
• Status: Active, not recruiting
• Start date: November 19, 2020
• Est. completion date: August 30, 2030

Study information

• Verified date: December 5, 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 118
• Est. completion date: August 30, 2030
• Est. primary completion date: August 30, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

• INCLUSION CRITERIA:

The study will use existing radiologic data.

EXCLUSION CRITERIA:

NONE

Related Conditions & MeSH terms

• Plaque, Atherosclerotic
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1/Measure atherosclerotic plaques	Measure atherosclerotic plaques on contrast-enhanced computed tomography (CECT)	End of study
Secondary	2/Plaque measurement and clinical biomarkers correlation	Find correlation between plaque measurement and clinical biomarkers of prostate cancer patients.	End of study

External Links

•   NIH Clinical Center Detailed Web Page