NCT03262818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2018

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

1.8 years

First QC Date

August 23, 2017

Last Update Submit

November 20, 2018

Conditions

Oophorectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Characterize the tissue images with 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

    At the time of surgery (no more than 30 days after PAI/US)

Study Arms (1)

Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging

EXPERIMENTAL

* 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 ultrasoundDevice: Ultrasound/Photoacoustic imaging

Interventions

Transvaginal ultrasoundDEVICE

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

Also known as: Transvaginal US
Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging
Ultrasound/Photoacoustic imagingDEVICE

-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.

Also known as: US/PAI
Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Cary L Siegel, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 25, 2017

Study Start

February 1, 2017

Primary Completion

November 19, 2018

Study Completion

November 20, 2018

Last Updated

November 23, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)