Clinical trial NCT04579237: Development and Evaluation of Techniques for Computer Aided Detection and Diagnosis From Existing Radiologic Images
Official title: Development and Evaluation of Techniques for Computer Aided Detection and Diagnosis From Existing Radiologic Images
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Radiology Information Systems
Keywords: Opportunistic screening
Artificial Intelligence
Automated Detection
Epidural Masses
Lymphadenopathy
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2020-10-08
Enrollment: 144625
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Special classes of subjects, such as pregnant women, children, cognitively impaired individuals, or others likely to be vulnerable will be included since the data has already been obtained under an IRB-approved protocol and there are no anticipated additional risks from this research

Brief 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.

Detailed 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

Eligibility criteria: * 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

Primary outcomes:
measure: Development of Computer Aided Detection techniques to improve radiology imaging
timeFrame: End of study
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institutes of Health Clinical Center (CC)
name: Ronald M Summers, M.D.
role: PRINCIPAL_INVESTIGATOR
References: