NCT05074537

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
49mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Jan 2019May 2030

Study Start

First participant enrolled

January 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2019

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

9.3 years

First QC Date

November 25, 2019

Last Update Submit

January 16, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Image quality

    We will be assessing image quality using a likert scale

    through study completion (roughly 10 years)

  • Anatomic Variability - Likert Scale

    through study completion (roughly 10 years)

  • Anatomic Variability - Length

    through study completion (roughly 10 years)

  • Anatomic Variability - Volume

    through study completion (roughly 10 years)

  • Anatomic Variability - Density

    through study completion (roughly 10 years)

Study Arms (3)

MRI Participants

Diagnostic Test: MRI exam

PET/CT Participants

Diagnostic Test: PET/CT imaging exam

CT Participants

Diagnostic Test: CT imaging exam

Interventions

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.

MRI Participants
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.

PET/CT Participants
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.

CT Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patient provides consent
  • Patient is receiving or has received a SOC or investigational imaging scan

You may not qualify if:

  • Patient does not wish to or is unable to provide consent
  • Patient is below the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martha Morehouse Medical Plaza

Columbus, Ohio, 43221, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 25, 2019

First Posted

October 12, 2021

Study Start

January 1, 2019

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2030

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations