Transvaginal Ultrasound and Photoacoustic Imaging of Ovary

Washington University School of Medicine185 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

185

Conditions

Ovary; Anomaly

Interventions

Photoacoustic imagingDEVICE

-Emerging technique in which a short-pulsed laser beam penetrates diffusively into a tissue sample

UltrasoundDEVICE

-The ultrasound is being used in conjunction with the photoacoustic imaging

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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%.

Time frame: At the time of surgery (estimated to be 2 weeks)

Secondary Outcomes

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%.

Time frame: At the time of surgery (estimated to be 2 weeks)

Data from ClinicalTrials.gov

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