Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary

Phase 1

Completed

• Conditions: Oophorectomy
• Interventions: Device: Transvaginal ultrasound; Device: Ultrasound/Photoacoustic imaging

• Registration Number: NCT03262818
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-25
• Status Verified: 2018-11
• Primary Completion: 2018-11-19
• Study Completion: 2018-11-20
• Last Update Submitted: 2018-11-20
• Last Update Posted: 2018-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging	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
Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging	Transvaginal ultrasound	* 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

Primary Outcome Measures

Name	Time	Method
Measure PAI/ultrasound signatures from ovaries prior to surgery	Prior to surgery (no more than 30 days 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.

Secondary Outcome Measures

Name	Time	Method
Characterize the tissue images with pathologic diagnosis	At the time of surgery (no more than 30 days after PAI/US)	-The in vivo and ex vivo PAI/US images with be compared with final pathologic diagnosis.
Refine the system and imaging algorithms based on the characteristic features of in vivo imaging	At the time of surgery (no more than 30 days after PAI/US)	-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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States