Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary

NCT ID: NCT03262818

Last Updated: 2018-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-11-20

Brief Summary

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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

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Conditions

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Oophorectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Transvaginal ultrasound

Intervention Type DEVICE

-Will be performed by US technologists at Washington University School of Medicine and read by Dr. Cary Siegel or Dr. Kathryn Robinson

Ultrasound/Photoacoustic imaging

Intervention Type DEVICE

-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.

Interventions

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Transvaginal ultrasound

-Will be performed by US technologists at Washington University School of Medicine and read by Dr. Cary Siegel or Dr. Kathryn Robinson

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Transvaginal US US/PAI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cary L Siegel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Related Links

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http://www.siteman.wustl.edu

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

Other Identifiers

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5R01CA151570-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201608016

Identifier Type: -

Identifier Source: org_study_id

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