Photoacoustic Imaging of the Ovary

Study Overview
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Brief Summary
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The purpose of this study is to develop technology to image the ovaries in order to better evaluate ovarian disease and to study how these experimental imaging techniques might work together or separately to improve our ability to detect ovarian cancer.

Detailed Description
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Epithelial ovarian cancer causes the highest mortality of any of the gynecologic cancers although it is the second most common gynecologic malignancy. Ovarian cancer is not usually detected earlier than Stage III or IV because it is usually asymptomatic; yet survival is high with early stage disease. In addition, women with a pelvic mass noted on ultrasound that undergo oophorectomy have only a 1-3% risk of malignancy and thus 97-99% will be overtreated because of our inability to reliably differentiate benign from malignant masses with ultrasound. BRCA1 testing and family history will identify certain high-risk individuals who have a higher risk of malignancy and need a modality that will be more reliable in detecting early cancers to provide more accurate surveillance.We are developing a new transvaginal imaging device optimized for ovarian cancer detection, diagnosis and validated from ex vivo and in vivo clinical studies. This automated system may provide an early diagnostic tool for ovarian cancer in the future.

Official Title
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Photoacoustic Imaging of the Ovary

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Device: PAI/ultrasound Diagnostic Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients, twenty one years or older, referred to the University of Connecticut for conditions necessitating oophorectomy. Patients cannot be pregnant or wish to become pregnant. Willingness to participate in the study. Exclusion Criteria: All Subjects who fail to meet the inclusion criteria are ineligible for the study.

Ages Eligible for Study
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Minimum Age: 21 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: PAI/ultrasound Diagnostic Group<br>These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy. | Device: PAI/ultrasound Diagnostic Group<br>* These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Measure Photoacoustic Imaging (PAI)/Ultrasound Signature From Ovaries Prior to Surgery Using the Ratio of Deoxy/Oxy Hb | To develop a method of analyzing PAI ovarian tissue images measuring oxy and deoxy hemoglobin as well as the ratio of deoxy/oxy Hb to recognize the presence of ovarian abnormalities and compare changes seen with ultrasound to changes seen with PAI. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic Diagnosis and in Vivo Imaging | To characterize the tissue images with pathologic diagnosis and to refine the system based on the characteristic features of in vivo imaging. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Cancer, Epithelial ovarian cancer