Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Cary L Siegel, M.D.
siegelc@wustl.edu
314-362-2928
Time Frame
Start Date: 2020-02-09
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 310
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov