Transvaginal Ultrasound and Photoacoustic Imaging of Ovary

NCT ID: NCT04178018

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-09
• Study Completion Date: 2027-01-31

Brief 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.

Detailed Description

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.

Conditions

Ovary; Anomaly

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Transvaginal photoacoustic imaging/ultrasound

• Baseline transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging for all participants enrolled
• Once the surgeon has surgically removed the ovary(ies), they will be imaged with the photoacoustic imaging/ultrasound
• For the exploratory outcome measure for high risk participants (approximately 50 participants), the transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging will be performed additionally at 6 months, 12 months, 18 months, 24 months, and at the time of surgery
• For the exploratory outcome measure for high risk participants (approximately 10 participants), the transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging will be performed additionally every 2 weeks at follicular phase and at the luteal phase for 3 months

Group Type: EXPERIMENTAL

Photoacoustic imaging

Intervention Type: DEVICE

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

Ultrasound

Intervention Type: DEVICE

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

Interventions

Photoacoustic imaging

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

Intervention Type: DEVICE

Ultrasound

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

Intervention Type: DEVICE

Other Intervention Names

PAI; Photoacoustic tomography

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• Male
• Younger than 18 years of age

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cary L Siegel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cary L Siegel, M.D.

Role: CONTACT

siegelc@wustl.edu

314-362-2928

Facility Contacts

Cary L Siegel, M.D.

Role: primary

siegelc@wustl.edu

314-362-2928

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

1R01CA237664-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201608016-2

Identifier Type: -

Identifier Source: org_study_id