Transvaginal Ultrasound and Photoacoustic Imaging of Ovary

Study Overview
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Brief Summary
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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
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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.

Official Title
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Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary

Conditions
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Ovary; Anomaly

Intervention / Treatment
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* Device: Photoacoustic imaging
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Primary and Secondary Outcome Measures All patients, 18 years or older, referred to the Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy. Willingness to participate in the study and able to provide informed consent. Inclusion Criteria for Exploratory Outcome Measures At least 18 years of age Referred to the Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy, an ovarian cystectomy, or a unilateral or bilateral salpingectomy . Willing to be followed for one to 4.5 years prior to making the decision to undergo prophylactic oophorectomy. Documented deleterious mutation in one of the following ovarian cancer genes: BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, PMS2, or EPCAM. Exclusion Criteria: Male Younger than 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transvaginal photoacoustic imaging/ultrasound<br>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 | Device: Photoacoustic imaging<br>* -Emerging technique in which a short-pulsed laser beam penetrates diffusively into a tissue sample<br>* Other names: Photoacoustic tomography;Device: Ultrasound<br>* -The ultrasound is being used in conjunction with the photoacoustic imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | The anticipated improvement of diagnostic accuracy on reduction of surgeries of benign ovaries will be from current practice of AUC=55% to AUC=78%. | Through completion of follow-up (estimated to be 4.5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| False negative rate of conventional imaging compared to conventional imaging & PAI/US as measured by sensitivity of cancer detection | The anticipated improvement of cancer detection accuracy will be from current practice of 80% to 94%. | Through completion of follow-up (estimated to be 4.5 years) |