Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary

The investigators have developed co-registered photoacoustic and ultrasound (US) imaging technique that allows the investigators to visualize tumor structure and functional changes simultaneously, which may potentially reveal early tumor angiogenesis development that is not available by US alone. The ability to detect early angiogenesis changes, as well as tumor morphology changes in the ovary, using a non-invasive imaging modality will greatly enhance the care for women.

Study Overview

• Status: Completed
• Conditions: Oophorectomy
• Intervention / Treatment: Device: Transvaginal ultrasound; Device: Ultrasound/Photoacoustic imaging

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 18 years of age or older
• Referred to Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy
• Willingness to participate in the study
• Able to provide informed consent

Exclusion Criteria

• Younger than 18 years of age
• Not able to provide informed consent

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 Ultrasound + Ultrasound/Photoacoustic imaging; Transvaginal ultrasound (US) prior to surgery; Immediately after the transvaginal US, US/PAI imaging will be performed; Once the surgeon has removed the ovary(ies) they will be imaged ex vivo. The in vivo and ex vivo US/PAI images will be compared with the final pathologic diagnosis

Device: Transvaginal ultrasound; -Will be performed by US technologists at Washington University School of Medicine and read by Dr. Cary Siegel or Dr. Kathryn Robinson; Other Names: Transvaginal US; Device: Ultrasound/Photoacoustic imaging; -The light illumination for the photoacoustic imaging system is provided by a wavelength-tunable Ti:Sapphire laser (LOTIS TII), optically pumped by an Nd:YAG laser (LOTIS TII) at 532 nm wavelength.; Other Names: US/PAI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure PAI/ultrasound signatures from ovaries prior to surgery	-The transvaginal US will be performed by US technologists or radiologists at the Radiology Department and images will be read by one of the study radiologists either Dr. Cary Siegel or Dr. Kathryn Robinson of the Radiology Department. The reading will be categorized as normal, suspicious or highly suspicious. The scores will serve as a baseline comparison of US/PAI technique with the current clinical practice using US. Immediately after the transvaginal US, US/PAI imaging will be performed with the assistance of the US technologist or radiologist.	Prior to surgery (no more than 30 days prior to surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the tissue images with pathologic diagnosis	-The in vivo and ex vivo PAI/US images with be compared with final pathologic diagnosis.	At the time of surgery (no more than 30 days after PAI/US)
Refine the system and imaging algorithms based on the characteristic features of in vivo imaging	-Will be used to distinguish between benign and malignant ovarian tissues. Student t-test will be used for statistical significant test of each feature obtained from malignant and benign ovaries. Those features with p value less than 0.05 will be used as a predictor.	At the time of surgery (no more than 30 days after PAI/US)

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 1, 2017
• Primary Completion (Actual): November 19, 2018
• Study Completion (Actual): November 20, 2018

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 20, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 201608016; 5R01CA151570-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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