Radiology Information SystemsNCT04579237
Development and Evaluation of Techniques for Computer Aided Detection and Diagnosis From Existing Radiologic Images
An observational study of Radiology Information Systems, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Radiology Information Systems
- How many people
- 144,625 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2020to 30 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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
- Conditions
- Radiology Information Systems
- Keywords
- Opportunistic screening, Artificial Intelligence, Automated Detection, Epidural Masses, Lymphadenopathy, Natural History
- Medical subject headings
- Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/All Subjects | Data will be derived from primary studies on all subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Computer Aided Detection techniques to improve radiology imaging
Development of Computer Aided Detection techniques to improve radiology imaging
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start5 Oct 2020
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiology Information SystemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 144,625 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ronald M Summers, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579237
- Sponsor's protocol ID
- 10000037
- Other IDs
- 000037-CC
- Status last verified
- 26 Sep 2025
- First submitted
- 7 Oct 2020
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Techniques for Computer Aided Detection and Diagnosis From Existing Radiologic Images
- ClinicalTrials.gov ID
- NCT04579237
- Acronym / sponsor ID
- 10000037
- Conditions
- Radiology Information Systems
- Keywords
- Opportunistic screening, Artificial Intelligence, Automated Detection, Epidural Masses, Lymphadenopathy, Natural History
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 144,625 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/All Subjects | – | –Data will be derived from primary studies on all subjects. |
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of Computer Aided Detection techniques to improve radiology imaging
Time frame: End of study
Development of Computer Aided Detection techniques to improve radiology imaging
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald M Summers, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiology Information Systems, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Computer Aided Detection techniques to improve radiology imaging (time frame: End of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.