Transvaginal Ultrasound and Photoacoustic Imaging of Ovary

Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary

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.

Study Overview

• Status: Recruiting
• Conditions: Ovary; Anomaly
• Intervention / Treatment: Device: Photoacoustic imaging; Device: Ultrasound

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.

• Study Type: Interventional
• Enrollment (Estimated): 310
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cary L Siegel, M.D.; Phone Number: 314-362-2928; Email: siegelc@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Sub-Investigator: Andrea Hagemann, M.D.
      • Sub-Investigator: Katherine Fuh, M.D., Ph.D.
      • Contact: Cary L Siegel, M.D.; Phone Number: 314-362-2928; Email: siegelc@wustl.edu
      • Principal Investigator: Cary L Siegel, M.D.
      • Sub-Investigator: William Middleton, M.D.
      • Sub-Investigator: Malak Itani, M.D.
      • Sub-Investigator: Anup Shetty, M.D.
      • Sub-Investigator: Valerie Ratts, M.D.
      • Sub-Investigator: Lindsay K Kuroki, M.D.
      • Sub-Investigator: Ian S Hagemann, M.D., Ph.D.
      • Sub-Investigator: Esther Lu, Ph.D.
      • Sub-Investigator: Matthew Powell, M.D.
      • Sub-Investigator: Carolyn McCourt, M.D.
      • Sub-Investigator: David Mutch, M.D.
      • Sub-Investigator: Quing Zhu, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Device: Photoacoustic imaging; -Emerging technique in which a short-pulsed laser beam penetrates diffusively into a tissue sample; Other Names: PAI; Photoacoustic tomography; Device: Ultrasound; -The ultrasound is being used in conjunction with the photoacoustic imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	At the time of surgery (estimated to be 2 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The investigators hope to improve current practice by detecting early cancers from this group of high-risk women	Through completion of follow-up (estimated to be 4.5 years)
Determine normal changes of photoacoustic imaging parameters	The investigators expect to see small changes of the PAI/US imaging parameters of less than 10-15 for repeated measurements of 3 menstrual cycles	Through completion of follow-up (estimated to be 4.5 years)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Cary L Siegel, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2020
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 201608016-2; 1R01CA237664-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Sharing of data collected by this project is essential to gain knowledge on how to improve and manage the current standard of care on high-risk and ovarian cancer patients.

The investigators will share data through multiple channels including:

• Publication of results and findings at various stages in peer-reviewed journals
• Presentation of results and findings at national and international conferences
• Public access to data collected from this project upon reasonable request when the study is completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No