Screening and Staging of Benign vs Malignant Pelvic Abnormalities
Clinical Evidence Generation of AI Enabled Fast, Accurate and Precise Screening and Staging of Benign vs Malignant Pelvic Abnormalities
3 other identifiers
observational
60
1 country
1
Brief Summary
This study evaluates whether newly developed non-FDA approved image processing techniques \[Adaptive Image Reconstruction (AIR Recon) Deep Learning (DL) and Sonic DL\] can provide improved quality and decreased time compared to current scanning techniques.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 4, 2025
CompletedFirst Submitted
Initial submission to the registry
February 6, 2026
CompletedFirst Posted
Study publicly available on registry
February 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2028
February 17, 2026
February 1, 2026
3.1 years
February 6, 2026
February 12, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Change in image quality (healthy volunteers)
Three expert radiologists will read scans (blinded to technique) and provide qualitative feedback to score image quality for standard of care (SOC) imaging, SOC with AirRecon DL, SOC with Sonic DL, and SOC with AirRecon DL and Sonic DL. Reader scoring will use a 1-5 Likert scale (1-5; 1:poor, 5:excellent).
Baseline
Change in scan time
Will be considered improved if the duration of the added imaging does not exceed 10 minutes
Baseline
Study Arms (1)
Observational
Participants undergo MRI on study.
Interventions
Non-interventional study
Eligibility Criteria
Healthy volunteers, patients referred for prostate MR and patients referred for endometriosis evaluation
You may qualify if:
- Patient over the age of 18
- For prostate group, any patient referred for prostate MR for screening purposes with no prior prostate related treatment or prior biopsy
- For endometriosis group, any patient referred for possible endometriosis evaluation (pre-surgical)
You may not qualify if:
- Individuals unable to undergo MRI imaging (MR-conditional or MR-nonconditional devices which would need additional procedures/conditions for scanning, pregnant people, individuals with implanted metal, etc.)
- Patient under the age of 18
- Patient who is unable to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Candice A. Bookwalter, MD, PhD
Mayo Clinic in Rochester
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2026
First Posted
February 12, 2026
Study Start
September 4, 2025
Primary Completion (Estimated)
September 30, 2028
Study Completion (Estimated)
September 30, 2028
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share