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Transvaginal Ultrasound and Photoacoustic Imaging of Ovary

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04178018
Recruitment Status : Not yet recruiting
First Posted : November 26, 2019
Last Update Posted : December 13, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
This study is being conducted to validate if photoacoustic imaging potentially reduces benign surgeries without compromising cancer detection sensitivity. The study will also explore whether using the photoacoustic imaging/ultrasound technique has any potential with early ovarian cancer detection in a group of high risk patients.

Condition or disease Intervention/treatment Phase
Ovary; Anomaly Device: Photoacoustic imaging Device: Ultrasound Not Applicable

Detailed Description:

In primary and secondary objectives, the investigators will consent patients who are at risk for ovarian cancer, or who have an ovarian mass possibly suggestive of a malignancy and are counseled to undergo oophorectomy. Patients will be identified by the GYN physicians and consented by the study coordinator prior to the date of the scheduled surgical procedure.

In exploratory objectives, the investigators will consent patients who are at risk for ovarian cancer and wish to be followed within one or two years before making decision to undergo prophylactic oophorectomy. Patients will be identified based on the eligibility criteria by the physicians and consented by the study coordinator prior to the follow up studies.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary
Estimated Study Start Date : January 15, 2020
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transvaginal photoacoustic imaging/ultrasound
  • Baseline transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging for all participants enrolled
  • Once the surgeon has surgically removed the ovary(ies), they will be imaged with the photoacoustic imaging/ultrasound
  • For the exploratory outcome measure for high risk participants (approximately 50 participants), the transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging will be performed additionally at 6 months, 12 months, 18 months, 24 months, and at the time of surgery
  • For the exploratory outcome measure for high risk participants (approximately 10 participants), the transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging will be performed additionally every 2 weeks at follicular phase and at the luteal phase for 3 months
Device: Photoacoustic imaging
-Emerging technique in which a short-pulsed laser beam penetrates diffusively into a tissue sample
Other Names:
  • PAI
  • Photoacoustic tomography

Device: Ultrasound
-The ultrasound is being used in conjunction with the photoacoustic imaging




Primary Outcome Measures :
  1. Assess the impact of co-registered PAI/US on the potential reduction of benign surgeries as measured by the area under receiver characteristic curve (AUC) [ Time Frame: Through completion of surgery for all participants (estimated to be 5 years) ]
    The anticipated improvement of diagnostic accuracy on reduction of surgeries of benign ovaries will be from current practice of AUC=55% to AUC=78%.


Secondary Outcome Measures :
  1. False negative rate of conventional imaging compared to conventional imaging & PAI/US as measured by sensitivity of cancer detection [ Time Frame: Through completion of surgery for all participants (estimated to be 5 years) ]
    The anticipated improvement of cancer detection accuracy will be from current practice of 80% to 94%.


Other Outcome Measures:
  1. Determine if co-registered PAI/US can be used as a sensitive and specific screening tool for early detection of malignant neoangiogenesis within a group of high-risk women [ Time Frame: Through completion of surgery for all participants (estimated to be 5 years) ]
    The investigators hope to improve current practice by detecting early cancers from this group of high-risk women

  2. Determine normal changes of photoacoustic imaging parameters [ Time Frame: Through completion of surgery for all participants (estimated to be 5 years) ]
    The investigators expect to see small changes of the PAI/US imaging parameters of less than 10-15 for repeated measurements of 3 menstrual cycles



Information from the National Library of Medicine

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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 for Primary and Secondary Outcome Measures

  • All patients, 18 years or older, referred to the Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy.
  • Willingness to participate in the study and able to provide informed consent.

Inclusion Criteria for Exploratory Outcome Measures -Willingness to participate in the monitoring study before risk reduction oophorectomy. --Premenopausal women with a documented deleterious mutation in one of the following ovarian cancer genes: BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, PMS2, or EPCAM.

*Menopause is defined as ≥ 12 months of amenorrhea. However, for those patients with ≥ 12 months of amenorrhea who may be pre-menopausal, levels of FSH, LH, and estradiol in the pre-menopausal range will be acceptable. Patients age will be in the range of 30 to 50 years old.

Exclusion Criteria:

  • Male
  • Younger than 18 years of age

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): NCT04178018


Contacts
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Contact: Cary L Siegel, M.D. 314-362-2928 siegelc@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Contact: Cary L Siegel, M.D.    314-362-2928    siegelc@wustl.edu   
Principal Investigator: Cary L Siegel, M.D.         
Sub-Investigator: Matthew Powell, M.D.         
Sub-Investigator: Andrea Hagemann, M.D.         
Sub-Investigator: William Middleton, M.D.         
Sub-Investigator: David Mutch, M.D.         
Sub-Investigator: Malak Itani, M.D.         
Sub-Investigator: Anup Shetty, M.D.         
Sub-Investigator: Valerie Ratts, M.D.         
Sub-Investigator: Lindsay K Kuroki, M.D.         
Sub-Investigator: Carolyn McCourt, M.D.         
Sub-Investigator: Katherine Fuh, M.D., Ph.D.         
Sub-Investigator: Ian S Hagemann, M.D., Ph.D.         
Sub-Investigator: Esther Lu, Ph.D.         
Sub-Investigator: Quing Zhu, Ph.D.         
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: NCT04178018    
Other Study ID Numbers: 201608016-2
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Sharing of data collected by this project is essential to gain knowledge on how to improve and manage the current standard of care on high-risk and ovarian cancer patients.

The investigators will share data through multiple channels including:

  • Publication of results and findings at various stages in peer-reviewed journals
  • Presentation of results and findings at national and international conferences
  • Public access to data collected from this project upon reasonable request when the study is completed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Congenital Abnormalities