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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 : Recruiting
First Posted : November 26, 2019
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE November 22, 2019
First Posted Date  ICMJE November 26, 2019
Last Update Posted Date February 17, 2020
Estimated Study Start Date  ICMJE February 10, 2020
Estimated Primary Completion Date January 31, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2019)
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%.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2019)
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%.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 22, 2019)
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Transvaginal Ultrasound and Photoacoustic Imaging of Ovary
Official Title  ICMJE Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Ovary; Anomaly
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Interventions:
  • Device: Photoacoustic imaging
  • Device: Ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 10, 2019)
230
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2019)
350
Estimated Study Completion Date  ICMJE January 31, 2027
Estimated Primary Completion Date January 31, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cary L Siegel, M.D. 314-362-2928 siegelc@wustl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04178018
Other Study ID Numbers  ICMJE 201608016-2
1R01CA237664-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Cary L Siegel, M.D. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP