Trials / Recruiting
RecruitingNCT04178018
Transvaginal Ultrasound and Photoacoustic Imaging of Ovary
Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 310 (estimated)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Photoacoustic imaging | -Emerging technique in which a short-pulsed laser beam penetrates diffusively into a tissue sample |
| DEVICE | Ultrasound | -The ultrasound is being used in conjunction with the photoacoustic imaging |
Timeline
- Start date
- 2020-02-09
- Primary completion
- 2027-01-31
- Completion
- 2027-01-31
- First posted
- 2019-11-26
- Last updated
- 2025-11-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04178018. Inclusion in this directory is not an endorsement.