Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary

The Washington University

Status and phase: Completed; Phase 1

Conditions: Oophorectomy

Treatments: Device: Transvaginal ultrasound; Device: Ultrasound/Photoacoustic imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03262818

201608016

5R01CA151570-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging

Experimental group

Description:

* 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

Treatment:

Device: Ultrasound/Photoacoustic imaging

Device: Transvaginal ultrasound