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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04579237
Other study ID # 10000037
Secondary ID 000037-CC
Status Active, not recruiting
Phase
First received
Last updated
Start date October 5, 2020
Est. completion date June 30, 2030

Study information

Verified date December 20, 2023
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background: Radiologic images are getting more complex. They are also being used more often. Medical personnel are overwhelmed with data. Computer Aided Detection (CAD) and diagnosis may be able to improve medical care. Researchers want to create and test ways to use CAD. To do this, they want to use data from the Clinical Center s Department of Diagnostic Radiology. Objective: To create algorithms and software that accurately detect and characterize lesions, model anatomy, and monitor diseases on radiologic studies. Eligibility: People of all ages who have radiologic exams stored in the clinical PACS (picture archiving system) of the Clinical Center since July 6, 1953 with no end date. People with target lesions of any kind will be included. Design: This study will use existing data. Participants will include males and females of all ages. They will be chosen by keyword search on NIH databases. The data that is used may include CT, MRI, ultrasound, and other images. It may include a participant s name, date of birth, and date of exam. It may include the name of the doctor, radiologist, and hospital. Data such as age, gender, race, disease, and treatment may be used. Other data from charts or studies may be used. Imaging data of all organs of the body will be studied. Data will be kept in computers and servers. The equipment will be password protected. Printouts will be stored in locked rooms. This study will last 10 years.


Description:

Study Description: This study uses artificial intelligence techniques to improve radiology diagnosis. Objective: Development of Computer Aided Detection techniques to improve radiology imaging. Study Population: Up to 1,000,000 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 144625
Est. completion date June 30, 2030
Est. primary completion date June 30, 2030
Accepts healthy volunteers No
Gender All
Age group 1 Year to 100 Years
Eligibility - INCLUSION CRITERIA: - All radiologic exams available in the clinical PACS (picture archiving system) of the Clinical Center taken from July, 6, 1953 with no end date. - Males and Females of all ages. - Patients with target lesions of any kind will be included - Patients without the target lesion will be included to determine the specificity of the computer aided detection or diagnosis algorithm EXCLUSION CRITERIA: None

Study Design


Related Conditions & MeSH terms


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 Development of Computer Aided Detection techniques to improve radiology imaging Development of Computer Aided Detection techniques to improve radiology imaging End of study