Clinical trial NCT04178018: Transvaginal Ultrasound and Photoacoustic Imaging of Ovary
Official title: Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovary; Anomaly
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-11-26
Enrollment: 310
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

* 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:

* Male
* Younger than 18 years of age

Primary outcomes:
measure: 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)
timeFrame: At the time of surgery (estimated to be 2 weeks)
Secondary outcomes:
measure: False negative rate of conventional imaging compared to conventional imaging & PAI/US as measured by sensitivity of cancer detection
timeFrame: At the time of surgery (estimated to be 2 weeks)
Other outcomes:
measure: 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
timeFrame: Through completion of follow-up (estimated to be 4.5 years)
measure: Determine normal changes of photoacoustic imaging parameters
timeFrame: Through completion of follow-up (estimated to be 4.5 years)
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Cary L Siegel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: