Photoacoustic Imaging of the Ovary

UConn Health2 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Ovarian Cancer

Interventions

PAI/ultrasound Diagnostic GroupDEVICE

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.

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (1)

UConn Health

Farmington, Connecticut, United States

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Secondary Outcomes

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.

Time frame: 5 years

Data from ClinicalTrials.gov

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