Development and Evaluation of Techniques for Computer Aided Detection and Diagnosis From Existing Radiologic Images

NCT ID: NCT04579237

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

144625 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-05

Study Completion Date

2030-06-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Radiology Information Systems

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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1/All Subjects

Data will be derived from primary studies on all subjects.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald M Summers, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institutes of Health Clinical Center (CC)

Locations

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National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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000037-CC

Identifier Type: -

Identifier Source: secondary_id

10000037

Identifier Type: -

Identifier Source: org_study_id

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