RecruitingNot ApplicableNCT04178018

Transvaginal Ultrasound and Photoacoustic Imaging of Ovary

Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary


Sponsor

Washington University School of Medicine

Enrollment

310 participants

Start Date

Feb 9, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • 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.
  • 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 Criteria2

  • Male
  • Younger than 18 years of age

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Interventions

DEVICEPhotoacoustic imaging

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

DEVICEUltrasound

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


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT04178018


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