Female Reproductive System Adnexal NeoplasmNCT07280312
Ultrasound Microvessel Imaging for the Evaluation of Ovarian and Adnexal Lesions
A study testing Transvaginal Ultrasound and Ultrasound Microvessel Imaging in people with Female Reproductive System Adnexal Neoplasm and Ovarian Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This clinical trial studies how well ultrasound microvessel imaging (UMI) works in evaluating ovarian and adnexal lesions in patients who are scheduled to have surgical treatment for their ovarian or adnexal lesions as part of their clinical care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Reproductive System Adnexal Neoplasm, Ovarian Carcinoma, Female Reproductive System Neoplasm
- What is being tested?
- Transvaginal Ultrasound and Ultrasound Microvessel Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2026to 17 Dec 2029
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥ 18 years
- Scheduled for surgery for ovarian or adnexal lesions
Who cannot join
- Prior surgical removal of ovarian or adnexal lesions
- Undergoing neoadjuvant chemotherapy or targeted systemic therapy
- Vulnerable populations, including prisoners, adults lacking capacity to consent, and pregnant women (our study coordinator will ask participants if they are pregnant; if uncertain, a urine pregnancy test will be offered at no cost).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Shigao D. Chen, PhD
About this study
Official title: Ultrasound Imaging of Ovarian and Adnexal Lesions
This clinical trial studies how well ultrasound microvessel imaging (UMI) works in evaluating ovarian and adnexal lesions in patients who are scheduled to have surgical treatment for their ovarian or adnexal lesions as part of their clinical care. Ovarian cancer is the most lethal gynecologic malignancy, often diagnosed at an advanced stage. Current diagnostic tools include a blood test (serum cancer antigen 125 [CA125]) and transvaginal ultrasound. However, CA125 has limited diagnostic accuracy and is Food and Drug Administration-approved only for monitoring the return of cancer (recurrence), not for preoperative diagnosis. A key measurement in calculating ovarian and adnexal cancer risk is by looking at increased blood flow, which may suggest a higher risk of cancer developing. However, current ultrasound techniques have limited ability to assess blood flow. A new ultrasound technique, UMI, may have higher sensitivity for detecting small blood vessels compared to traditional ultrasound imaging.
- Conditions
- Female Reproductive System Adnexal Neoplasm, Ovarian Carcinoma, Female Reproductive System Neoplasm, Ovarian Neoplasms, Adnexal Lesion, Ovarian Lesion
- Being tested
- Transvaginal Ultrasound, Ultrasound Microvessel Imaging
- Medical subject headings
- Ovarian Neoplasms, Genital Neoplasms, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal UltrasoundProcedure or surgery
Also called transvaginal sonography, TVS, TVU
Undergo transvaginal ultrasound
Ultrasound Microvessel ImagingProcedure or surgery
Also called 3D Ultrasound Microvessel Imaging, UMI
Undergo UMI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (UMI, transvaginal ultrasound) | Experimental | Patients undergo UMI during standard transvaginal ultrasound imaging procedure on study. Receives: Procedure: Transvaginal Ultrasound; Procedure: Ultrasound Microvessel Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in O-RADS score
Ovarian-Adnexal Reporting and Data System (O-RADS) scores will be initially based on B-mode and Doppler imaging (standard of care) obtained prior to surgical treatment. Radiologists will then review ultrasound microvessel imaging (UMI) images and may choose to revise the score. Accuracy of score adjustments will be assessed using final pathology results from the participant's medical record.
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 Dec 2025
- Study start22 Jan 2026
- Primary completion17 Dec 2027 (estimated)
- Study completion17 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Reproductive System Adnexal NeoplasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shigao D. Chen, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280312
- Sponsor's protocol ID
- 25-008495
- Other IDs
- NCI-2025-08526, 25-008495
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Imaging of Ovarian and Adnexal Lesions
- ClinicalTrials.gov ID
- NCT07280312
- Acronym / sponsor ID
- 25-008495
- Conditions
- Female Reproductive System Adnexal Neoplasm, Ovarian Carcinoma, Female Reproductive System Neoplasm, Ovarian Neoplasms, Adnexal Lesion, Ovarian Lesion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 17 Dec 2027 (estimated)
- Study completion
- 17 Dec 2029 (estimated)
- First posted
- 12 Dec 2025 (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 clinical trial studies how well ultrasound microvessel imaging (UMI) works in evaluating ovarian and adnexal lesions in patients who are scheduled to have surgical treatment for their ovarian or adnexal lesions as part of their clinical care. Ovarian cancer is the most lethal gynecologic malignancy, often diagnosed at an advanced stage. Current diagnostic tools include a blood test (serum cancer antigen 125 [CA125]) and transvaginal ultrasound. However, CA125 has limited diagnostic accuracy and is Food and Drug Administration-approved only for monitoring the return of cancer (recurrence), not for preoperative diagnosis. A key measurement in calculating ovarian and adnexal cancer risk is by looking at increased blood flow, which may suggest a higher risk of cancer developing. However, current ultrasound techniques have limited ability to assess blood flow. A new ultrasound technique, UMI, may have higher sensitivity for detecting small blood vessels compared to traditional ultrasound imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (UMI, transvaginal ultrasound) | Experimental | Procedure: Transvaginal Ultrasound, Procedure: Ultrasound Microvessel ImagingPatients undergo UMI during standard transvaginal ultrasound imaging procedure on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female patients aged ≥ 18 years
- Scheduled for surgery for ovarian or adnexal lesions
Key exclusion criteria (3 listed)
- Prior surgical removal of ovarian or adnexal lesions
- Undergoing neoadjuvant chemotherapy or targeted systemic therapy
- Vulnerable populations, including prisoners, adults lacking capacity to consent, and pregnant women (our study coordinator will ask participants if they are pregnant; if uncertain, a urine pregnancy test will be offered at no cost).
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 |
|---|---|---|
| Transvaginal UltrasoundAlso: transvaginal sonography, TVS, TVUUndergo transvaginal ultrasound | Procedure or surgery | Diagnostic (UMI, transvaginal ultrasound) |
| Ultrasound Microvessel ImagingAlso: 3D Ultrasound Microvessel Imaging, UMIUndergo UMI | Procedure or surgery | Diagnostic (UMI, transvaginal ultrasound) |
Primary outcome
Change in O-RADS score
Time frame: Baseline
Ovarian-Adnexal Reporting and Data System (O-RADS) scores will be initially based on B-mode and Doppler imaging (standard of care) obtained prior to surgical treatment. Radiologists will then review ultrasound microvessel imaging (UMI) images and may choose to revise the score. Accuracy of score adjustments will be assessed using final pathology results from the participant's medical record.
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 3 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Shigao D. Chen, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal Ultrasound and Ultrasound Microvessel Imaging in people with Female Reproductive System Adnexal Neoplasm and Ovarian 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 2 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 3 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 O-RADS score (time frame: Baseline). 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 3 Feb 2026.