[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07280312":3,"trial-entities:NCT07280312":99,"trial-summary:NCT07280312":104},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":51,"secondary_outcomes":56,"sex":57,"minimum_age":58,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":68,"locations":71,"central_contacts":90,"overall_officials":92,"references":94,"see_also_links":95},"NCT07280312","25-008495","Ultrasound Microvessel Imaging for the Evaluation of Ovarian and Adnexal Lesions","Ultrasound Imaging of Ovarian and Adnexal Lesions","RECRUITING","2029-12-17","2026-01","2026-02-03","2026-01-22","Mayo Clinic","OTHER",false,"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.",null,[19,20,21,22,23,24],"Female Reproductive System Adnexal Neoplasm","Ovarian Carcinoma","Female Reproductive System Neoplasm","Ovarian Neoplasms","Adnexal Lesion","Ovarian Lesion",[],"INTERVENTIONAL","DIAGNOSTIC",[29],"NA",{"count":31,"type":32},40,"ESTIMATED",[34,44],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":40},"PROCEDURE","Transvaginal Ultrasound","Undergo transvaginal ultrasound",[39],"Diagnostic (UMI, transvaginal ultrasound)",[41,42,43],"transvaginal sonography","TVS","TVU",{"type":35,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Ultrasound Microvessel Imaging","Undergo UMI",[39],[49,50],"3D Ultrasound Microvessel Imaging","UMI",[52],{"measure":53,"description":54,"timeFrame":55},"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.","Baseline",[],"FEMALE","18 Years",{"inclusion":60,"exclusion":63,"raw_text":67},[61,62],"Female patients aged ≥ 18 years","Scheduled for surgery for ovarian or adnexal lesions",[64,65,66],"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).","Inclusion Criteria:\n\n* Female patients aged ≥ 18 years\n* Scheduled for surgery for ovarian or adnexal lesions\n\nExclusion Criteria:\n\n* Prior surgical removal of ovarian or adnexal lesions\n* Undergoing neoadjuvant chemotherapy or targeted systemic therapy\n* 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).",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":87},"Mayo Clinic in Rochester","Rochester","Minnesota","55905","United States",[79,84],{"name":80,"role":81,"phone":82,"email":83},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",{"name":85,"role":86},"Shigao D. Chen, PhD","PRINCIPAL_INVESTIGATOR",{"lat":88,"lon":89},44.02163,-92.4699,[91],{"name":80,"role":81,"phone":82,"email":83},[93],{"name":85,"affiliation":13,"role":86},[],[96],{"label":97,"url":98},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":100,"biomarkers":103},[101,102],"Adnexal Neoplasm","Malignant Ovarian Neoplasm",[],{"nct_id":4,"found":105,"summary":106,"prompt_version":116},true,{"design":107,"status":108,"heading":109,"summary":110,"follow_up":111,"word_count":112,"commitments":113,"compensation":114,"drugs_mentioned":115},"This is an interventional study with a planned enrollment of 40 women. The phase of the study is not specified.","completed","Ultrasound Microvessel Imaging for Ovarian and Adnexal Lesions","This study is looking at how well a new imaging technique, Ultrasound Microvessel Imaging (UMI), works to evaluate ovarian and adnexal lesions (growths near the ovaries). Ovarian cancer is often found at a late stage, and current tests like blood tests (CA125) and standard ultrasounds have limitations. UMI aims to improve how we assess these lesions by looking at blood flow, which can indicate a higher risk of cancer. You may be able to join if you are a woman aged 18 or older and are scheduled for surgery for an ovarian or adnexal lesion. The study will measure changes in your O-RADS score (a system for classifying ovarian and adnexal lesions) at the start of the study. The current status of this study is unclear, and it plans to enroll 40 participants.","The primary endpoint, change in O-RADS score, is measured at baseline, so no long-term follow-up is specified.",133,"You would undergo a transvaginal ultrasound and Ultrasound Microvessel Imaging (UMI).","Not stated in the trial record.",[45],"v2"]