Screening and Staging of Benign vs Malignant Pelvic Abnor... | NCT07407959

Studies
Screening and Staging of Benign vs Malignant Pelvic Abnormalities

NCT07407959

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

Feb 17, 2026Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Endometrial Carcinoma
Prostate Carcinoma

Interventions

Non-Interventional Study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2025-09210	Registry Identifier	CTRP (Clinical Trial Reporting Program)
24-011490	Other Identifier	Mayo Clinic Institutional Review Board

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 4, 2025Actual

Primary Completion Date

Sep 30, 2028Estimated

Completion Date

Sep 30, 2028Estimated

First Submitted Date

Feb 6, 2026

First Submission Date that Met QC Criteria

Feb 6, 2026

First Posted Date

Feb 12, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2026

Last Update Posted Date

Feb 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational		Participants undergo MRI on study.	Other: Non-Interventional Study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional Study	Other	Non-interventional study	Observational

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy volunteers, patients referred for prostate MR and patients referred for endometriosis evaluation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Trials Referral Office	Contact	855-776-0015		mayocliniccancerstudies@mayo.edu
Bobbie Ott	Contact	507-293-0922

Overall Officials

Name	Affiliation	Role
Candice A. Bookwalter, MD, PhD	Mayo Clinic in Rochester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester	Recruiting	Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016889	Endometrial Neoplasms
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided