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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07407959
Enrollment
60
Registered
2026-02-12
Start date
2025-09-04
Completion date
2028-09-30
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Carcinoma, Prostate Carcinoma

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.

Interventions

OTHERNon-Interventional Study

Non-interventional study

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in image quality (healthy volunteers)BaselineThree 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).
Change in scan timeBaselineWill be considered improved if the duration of the added imaging does not exceed 10 minutes

Countries

United States

Contacts

CONTACTClinical Trials Referral Office
mayocliniccancerstudies@mayo.edu855-776-0015
CONTACTBobbie Ott
507-293-0922
PRINCIPAL_INVESTIGATORCandice A. Bookwalter, MD, PhD

Mayo Clinic in Rochester

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026