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Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT03262818
Collaborator
National Cancer Institute (NCI) (NIH)
40
Enrollment
1
Location
1
Arm
21.6
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transvaginal ultrasound
  • Device: Ultrasound/Photoacoustic imaging
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary
Actual Study Start Date :
Feb 1, 2017
Actual Primary Completion Date :
Nov 19, 2018
Actual Study Completion Date :
Nov 20, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University School of Medicine Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Washington University School of Medicine
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Cary L Siegel, M.D., Washington University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT03262818
    Other Study ID Numbers:
    • 201608016
    • 5R01CA151570-02
    First Posted:
    Aug 25, 2017
    Last Update Posted:
    Nov 23, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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

    Study Results

    No Results Posted as of Nov 23, 2018