Endometrial CarcinomaNCT07407959
Screening and Staging of Benign vs Malignant Pelvic Abnormalities
An observational study of Endometrial Carcinoma and Prostate Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endometrial Carcinoma, Prostate Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2025to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers, patients referred for prostate MR and patients referred for endometriosis evaluation
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bobbie Ott contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Bobbie Ott, 507-293-0922
About this study
Official title: Clinical Evidence Generation of AI Enabled Fast, Accurate and Precise 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.
- Conditions
- Endometrial Carcinoma, Prostate Carcinoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Endometrial Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Also called Non-Interventional Observational Study, Noninterventional (Observational) Study
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Participants undergo MRI on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Change in scan time
Will be considered improved if the duration of the added imaging does not exceed 10 minutes
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start4 Sep 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Candice A. Bookwalter, MD, PhD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407959
- Sponsor's protocol ID
- MCBookwalter
- Other IDs
- NCI-2025-09210, 24-011490
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evidence Generation of AI Enabled Fast, Accurate and Precise Screening and Staging of Benign vs Malignant Pelvic Abnormalities
- ClinicalTrials.gov ID
- NCT07407959
- Acronym / sponsor ID
- MCBookwalter
- Conditions
- Endometrial Carcinoma, Prostate Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyParticipants undergo MRI on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers, patients referred for prostate MR and patients referred for endometriosis evaluation
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyAlso: Non-Interventional Observational Study, Noninterventional (Observational) StudyNon-interventional study | Other | Observational |
Primary outcome
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).
Change in scan time
Time frame: Baseline
Will be considered improved if the duration of the added imaging does not exceed 10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bobbie Ott contact
Candice A. Bookwalter, MD, PhD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Carcinoma and Prostate Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in image quality (healthy volunteers) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.