Medical Imaging DataWIIANCT05074537
The Wright Center of Innovation Imaging Archive
An observational study of Medical Imaging Data, run by University of Cincinnati at 1 site in United States.
Trial summary
This data bank will serve as a data resource for a multidisciplinary team of clinicians and basic scientists. Specifically, this data bank will allow investigators to generate preliminary data for competitive consideration in intermural and extramural funding while enabling advanced analytical tool development and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Imaging Data
- What is being tested?
- MRI exam, PET/CT imaging exam and CT imaging exam
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to May 2030
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient population under study includes adults who are 18 years of age and older. Children will be excluded from this study as they are unable to give voluntary consent. A partial waiver of HIPAA authorization will be requested to permit access to and use of PHI for recruitment purposes. However, investigational data will only be collected once consent to participate in the study is acquired. Participants can include or donate their imaging data independently if it was performed at OSU or outside of OSU. For example, a subject may be willing to donate an imaging study performed previously or for different purposes and provides the WIIA with a CD or other data set. There will be no upper limit to the number of people who participate in this study. We expect 100-150 participants per year, with plans for the study to continue indefinitely.
Who may be able to join
- Patient provides consent
- Patient is receiving or has received a SOC or investigational imaging scan
Who cannot join
- Patient does not wish to or is unable to provide consent
- Patient is below the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Martha Morehouse Medical Plaza
Columbus, Ohio, 43221
About this study
Official title: The WIIA - The Wright Center of Innovation Imaging Archive
This data bank will serve as a data resource for a multidisciplinary team of clinicians and basic scientists. Specifically, this data bank will allow investigators to generate preliminary data for competitive consideration in intermural and extramural funding while enabling advanced analytical tool development and deep learning methodologies. This effort will enable the use for leading edge innovation in biomedical imaging by using clinical imaging studies that otherwise could not be used for such developments. We aim to use these data to improve diagnostics and disease management. With this data bank, we hope to improve the quality of imaging and the precision of imaging based analytics to better detect potential health risks, predict treatment response, and monitor disease progression in order to guide management of future patients.
Read the detailed description
The constant advances in computational capabilities and abilities of deep learning necessitate the availability of large imaging data sets that can be further analyzed. We therefore create the WIIA - The Wright Center of Innovation Imaging Archive - to serve as a repository for advanced data analytics and simulation. This will provide researchers access to a robust, comprehensive pool of imaging data for impactful research. The patient population under study includes adults who are 18 years of age and older. Children will be excluded from this study as they are unable to give voluntary consent. A partial waiver of HIPAA authorization will be requested to permit access to and use of PHI for recruitment purposes. However, investigational data will only be collected once consent to participate in the study is acquired. There will be no upper limit to the number of people who participate in this study. We expect 100-150 participants per year, with plans for the study to continue indefinitely. Data collected will include coded demographics, abbreviated medical history, current diagnoses, coded medical reports, coded surgical/nonsurgical treatment procedures, and follow up information. These data will be collected from Standard of Care (SOC) or investigational imaging studies. These data will be coded and stored in the Wright Center of Innovation Imaging Archive, which is a secure database of imaging studies. Data will be stored indefinitely. Administrative staff will construct and maintain the database as well as conduct annual quality assurance assessments of bank data. Oversight of the bank will be the responsibility of the Principal and Co-Investigators of the study. To maximize the use of this data bank and to promote collaborative, multi-institutional research, we are not limiting future data use. Data may be shared with Ohio State or non-Ohio State researchers. However, only investigators with sound, hypothesis driven research proposals can request data by completing a Data Request Form. This study will impose minimal medical risk to participants. At data leak is the primary risk, which will be minimized through precautions to protect PHI. Nevertheless, in the event of a data breach, the nature of the collected data ensures minimal financial or professional impact on the patient. This study does not confer a direct benefit to the patient. However, society may benefit from imaging advancements that arise from future studies using this data.
- Conditions
- Medical Imaging Data
- Being tested
- MRI exam, PET/CT imaging exam, CT imaging exam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI examDiagnostic test
Participants who are receiving standard of care or investigational MRI exams at the Wright Center will be eligible for enrollment in this data bank.
PET/CT imaging examDiagnostic test
Participants who are receiving standard of care or investigational PET/CT exams at the Wright Center will be eligible for enrollment in this data bank.
CT imaging examDiagnostic test
Participants who are receiving standard of care or investigational CT exams at the Wright Center will be eligible for enrollment in this data bank.
| Study group | Role | What they receive |
|---|---|---|
| MRI Participants | Not described Receives: Diagnostic Test: MRI exam | |
| PET/CT Participants | Not described Receives: Diagnostic Test: PET/CT imaging exam | |
| CT Participants | Not described Receives: Diagnostic Test: CT imaging exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality
We will be assessing image quality using a likert scale
Measured: through study completion (roughly 10 years)
Anatomic Variability - Likert Scale
Measured: through study completion (roughly 10 years)
Anatomic Variability - Length
Measured: through study completion (roughly 10 years)
Anatomic Variability - Volume
Measured: through study completion (roughly 10 years)
Anatomic Variability - Density
Measured: through study completion (roughly 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start1 Jan 2019
- Primary completionMay 2028 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Imaging DataStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael V Knopp MD PhD, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074537
- Sponsor's protocol ID
- RP0310/2017H0429
- Acronym
- WIIA
- Status last verified
- Jan 2024
- First submitted
- 25 Nov 2019
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The WIIA - The Wright Center of Innovation Imaging Archive
- ClinicalTrials.gov ID
- NCT05074537
- Acronym / sponsor ID
- WIIA / RP0310/2017H0429
- Conditions
- Medical Imaging Data
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 12 Oct 2021 (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.
This data bank will serve as a data resource for a multidisciplinary team of clinicians and basic scientists. Specifically, this data bank will allow investigators to generate preliminary data for competitive consideration in intermural and extramural funding while enabling advanced analytical tool development and deep learning methodologies. This effort will enable the use for leading edge innovation in biomedical imaging by using clinical imaging studies that otherwise could not be used for such developments. We aim to use these data to improve diagnostics and disease management. With this data bank, we hope to improve the quality of imaging and the precision of imaging based analytics to better detect potential health risks, predict treatment response, and monitor disease progression in order to guide management of future patients.
Detailed description
The constant advances in computational capabilities and abilities of deep learning necessitate the availability of large imaging data sets that can be further analyzed. We therefore create the WIIA - The Wright Center of Innovation Imaging Archive - to serve as a repository for advanced data analytics and simulation. This will provide researchers access to a robust, comprehensive pool of imaging data for impactful research. The patient population under study includes adults who are 18 years of age and older. Children will be excluded from this study as they are unable to give voluntary consent. A partial waiver of HIPAA authorization will be requested to permit access to and use of PHI for recruitment purposes. However, investigational data will only be collected once consent to participate in the study is acquired. There will be no upper limit to the number of people who participate in this study. We expect 100-150 participants per year, with plans for the study to continue indefinitely. Data collected will include coded demographics, abbreviated medical history, current diagnoses, coded medical reports, coded surgical/nonsurgical treatment procedures, and follow up information. These data will be collected from Standard of Care (SOC) or investigational imaging studies. These data will be coded and stored in the Wright Center of Innovation Imaging Archive, which is a secure database of imaging studies. Data will be stored indefinitely. Administrative staff will construct and maintain the database as well as conduct annual quality assurance assessments of bank data. Oversight of the bank will be the responsibility of the Principal and Co-Investigators of the study. To maximize the use of this data bank and to promote collaborative, multi-institutional research, we are not limiting future data use. Data may be shared with Ohio State or non-Ohio State researchers. However, only investigators with sound, hypothesis driven research proposals can request data by completing a Data Request Form. This study will impose minimal medical risk to participants. At data leak is the primary risk, which will be minimized through precautions to protect PHI. Nevertheless, in the event of a data breach, the nature of the collected data ensures minimal financial or professional impact on the patient. This study does not confer a direct benefit to the patient. However, society may benefit from imaging advancements that arise from future studies using this data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MRI Participants | – | Diagnostic Test: MRI exam |
| PET/CT Participants | – | Diagnostic Test: PET/CT imaging exam |
| CT Participants | – | Diagnostic Test: CT imaging exam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population under study includes adults who are 18 years of age and older. Children will be excluded from this study as they are unable to give voluntary consent. A partial waiver of HIPAA authorization will be requested to permit access to and use of PHI for recruitment purposes. However, investigational data will only be collected once consent to participate in the study is acquired. Participants can include or donate their imaging data independently if it was performed at OSU or outside of OSU. For example, a subject may be willing to donate an imaging study performed previously or for different purposes and provides the WIIA with a CD or other data set. There will be no upper limit to the number of people who participate in this study. We expect 100-150 participants per year, with plans for the study to continue indefinitely.
Key inclusion criteria (2 listed)
- Patient provides consent
- Patient is receiving or has received a SOC or investigational imaging scan
Key exclusion criteria (2 listed)
- Patient does not wish to or is unable to provide consent
- Patient is below the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI examParticipants who are receiving standard of care or investigational MRI exams at the Wright Center will be eligible for enrollment in this data bank. | Diagnostic test | MRI Participants |
| PET/CT imaging examParticipants who are receiving standard of care or investigational PET/CT exams at the Wright Center will be eligible for enrollment in this data bank. | Diagnostic test | PET/CT Participants |
| CT imaging examParticipants who are receiving standard of care or investigational CT exams at the Wright Center will be eligible for enrollment in this data bank. | Diagnostic test | CT Participants |
Primary outcome
Image quality
Time frame: through study completion (roughly 10 years)
We will be assessing image quality using a likert scale
Anatomic Variability - Likert Scale
Time frame: through study completion (roughly 10 years)
Anatomic Variability - Length
Time frame: through study completion (roughly 10 years)
Anatomic Variability - Volume
Time frame: through study completion (roughly 10 years)
Anatomic Variability - Density
Time frame: through study completion (roughly 10 years)
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 18 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Medical Imaging Data, run by University of Cincinnati 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 2 inclusion and 2 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 18 Jan 2024. 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?
Image quality (time frame: through study completion (roughly 10 years)). The study lists 5 primary outcomes in all. 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 18 Jan 2024.