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Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary

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ClinicalTrials.gov Identifier: NCT03262818
Recruitment Status : Completed
First Posted : August 25, 2017
Last Update Posted : November 23, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Oophorectomy Device: Transvaginal ultrasound Device: Ultrasound/Photoacoustic imaging Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : February 1, 2017
Actual Primary Completion Date : November 19, 2018
Actual Study Completion Date : November 20, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: US/PAI




Primary Outcome Measures :
  1. Measure PAI/ultrasound signatures from ovaries prior to surgery [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262818


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Cary L Siegel, M.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03262818    
Other Study ID Numbers: 201608016
5R01CA151570-02 ( U.S. NIH Grant/Contract )
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: November 23, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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