Photoacoustic Imaging of the Ovary

UConn Health

Status: Terminated

Conditions: Ovarian Cancer

Treatments: Device: PAI/ultrasound Diagnostic Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02110277

R01CA151570 (U.S. NIH Grant/Contract)

14-139S-3

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

PAI/ultrasound Diagnostic Group

Experimental group

Description:

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.

Treatment:

Device: PAI/ultrasound Diagnostic Group