Transvaginal Ultrasound and Photoacoustic Imaging of Ovary

NCT04178018 | Recruiting DMC FDA Device

• 2 other identifiers: 201608016-21R01CA237664-01A1
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovary; Anomaly

Outcome Measures

Primary Outcomes (1)

• 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%.

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

Secondary Outcomes (1)

• False negative rate of conventional imaging compared to conventional imaging & PAI/US as measured by sensitivity of cancer detection

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

Other Outcomes (2)

• Determine if co-registered PAI/US can be used as a sensitive and specific screening tool for early detection of malignant neoangiogenesis within a group of high-risk women

  Through completion of follow-up (estimated to be 4.5 years)

• Determine normal changes of photoacoustic imaging parameters

  Through completion of follow-up (estimated to be 4.5 years)

Study Arms (1)

Transvaginal photoacoustic imaging/ultrasound

EXPERIMENTAL

* 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

Device: Photoacoustic imaging; Device: Ultrasound

Interventions

Photoacoustic imaging DEVICE

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

Also known as: PAI, Photoacoustic tomography

Transvaginal photoacoustic imaging/ultrasound

Ultrasound DEVICE

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

Transvaginal photoacoustic imaging/ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Male
• Younger than 18 years of age

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Cary L Siegel, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cary L Siegel, M.D.

CONTACT

314-362-2928; siegelc@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 26, 2019
• Study Start: February 9, 2020
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)