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OpenTrials
Recruiting

NCT Number: NCT07407959

Screening and Staging of Benign vs Malignant Pelvic Abnormalities

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.

Recruiting

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Key information

Conditions

Endometrial Carcinoma Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Carcinoma Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Bobbie Ott

CONTACT

507-293-0922

Candice A. Bookwalter, MD, PhD

PRINCIPAL_INVESTIGATOR

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Other names: Non-Interventional Observational Study, Noninterventional (Observational) Study

Primary outcomes

  1. Change in image quality (healthy volunteers)

    Time frame: Baseline

    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).

  2. Change in scan time

    Time frame: Baseline

    Will be considered improved if the duration of the added imaging does not exceed 10 minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Bobbie Ott

CONTACT

507-293-0922

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Clinical Evidence Generation of AI Enabled Fast, Accurate and Precise Screening and Staging of Benign vs Malignant Pelvic Abnormalities

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 12, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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