Transvaginal Ultrasound and Photoacoustic Imaging of Ovary

Not Applicable

Recruiting

• Conditions: Ovary; Anomaly
• Interventions: Device: Photoacoustic imaging; Device: Ultrasound

• Registration Number: NCT04178018
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This study is being conducted to validate if photoacoustic imaging potentially reduces benign surgeries without compromising cancer detection sensitivity. The study will also explore whether using the photoacoustic imaging/ultrasound technique has any potential with early ovarian cancer detection in a group of high risk patients.

Detailed Description

In primary and secondary objectives, the investigators will consent patients who are at risk for ovarian cancer, or who have an ovarian mass possibly suggestive of a malignancy and are counseled to undergo oophorectomy. Patients will be identified by the GYN physicians and consented by the study coordinator prior to the date of the scheduled surgical procedure.

In exploratory objectives, the investigators will consent patients who are at risk for ovarian cancer and wish to be followed before making decision to undergo prophylactic oophorectomy. Patients will be identified based on the eligibility criteria by the physicians and consented by the study coordinator prior to the follow up studies.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-11-22
• Study First Posted: 2019-11-26
• Study Start: 2020-02-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 310

Inclusion Criteria

Not provided

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Exclusion Criteria

• Male
• Younger than 18 years of age

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transvaginal photoacoustic imaging/ultrasound	Ultrasound	* Baseline transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging for all participants enrolled * Once the surgeon has surgically removed the ovary(ies), they will be imaged with the photoacoustic imaging/ultrasound * For the exploratory outcome measure for high risk participants (approximately 50 participants), the transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging will be performed additionally at 6 months, 12 months, 18 months, 24 months, and at the time of surgery * For the exploratory outcome measure for high risk participants (approximately 10 participants), the transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging will be performed additionally every 2 weeks at follicular phase and at the luteal phase for 3 months
Transvaginal photoacoustic imaging/ultrasound	Photoacoustic imaging	* Baseline transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging for all participants enrolled * Once the surgeon has surgically removed the ovary(ies), they will be imaged with the photoacoustic imaging/ultrasound * For the exploratory outcome measure for high risk participants (approximately 50 participants), the transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging will be performed additionally at 6 months, 12 months, 18 months, 24 months, and at the time of surgery * For the exploratory outcome measure for high risk participants (approximately 10 participants), the transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging will be performed additionally every 2 weeks at follicular phase and at the luteal phase for 3 months

Primary Outcome Measures

Name	Time	Method
Assess the impact of co-registered PAI/US on the potential reduction of benign surgeries as measured by the area under receiver characteristic curve (AUC)	At the time of surgery (estimated to be 2 weeks)	The anticipated improvement of diagnostic accuracy on reduction of surgeries of benign ovaries will be from current practice of AUC=55% to AUC=78%.

Secondary Outcome Measures

Name	Time	Method
False negative rate of conventional imaging compared to conventional imaging & PAI/US as measured by sensitivity of cancer detection	At the time of surgery (estimated to be 2 weeks)	The anticipated improvement of cancer detection accuracy will be from current practice of 80% to 94%.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States