Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 185
- Locations
- 2
- Primary Endpoint
- 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)
Study Overview
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 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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •At least 18 years of age
- •Referred to the Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy, an ovarian cystectomy, or a unilateral or bilateral salpingectomy .
- •Willing to be followed for one to 4.5 years prior to making the decision to undergo prophylactic oophorectomy.
- •Documented deleterious mutation in one of the following ovarian cancer genes: BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, PMS2, or EPCAM.
Exclusion Criteria
- •Younger than 18 years of age
Arms & Interventions
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
Intervention: Photoacoustic imaging (Device)
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
Intervention: Ultrasound (Device)
Outcomes
Primary Outcomes
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: At the time of surgery (estimated to be 2 weeks)
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 Outcomes
- False negative rate of conventional imaging compared to conventional imaging & PAI/US as measured by sensitivity of cancer detection(At the time of surgery (estimated to be 2 weeks))