Transvaginal Ultrasound and Photoacoustic Imaging of Ovary

Ovary; Anomaly Clinical Trial

Official title:

Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04178018
• Other study ID #: 201608016-2
• Secondary ID: 1R01CA237664-01A
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2020
• Est. completion date: January 31, 2027

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: Cary L Siegel, M.D.
• Phone: 314-362-2928
• Email: siegelc[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovary; Anomaly

Intervention

Device:
• Photoacoustic imaging
-Emerging technique in which a short-pulsed laser beam penetrates diffusively into a tissue sample
• Ultrasound
-The ultrasound is being used in conjunction with the photoacoustic imaging

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	The investigators hope to improve current practice by detecting early cancers from this group of high-risk women	Through completion of follow-up (estimated to be 4.5 years)
Other	Determine normal changes of photoacoustic imaging parameters	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	Through completion of follow-up (estimated to be 4.5 years)
Primary	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)	The anticipated improvement of diagnostic accuracy on reduction of surgeries of benign ovaries will be from current practice of AUC=55% to AUC=78%.	At the time of surgery (estimated to be 2 weeks)
Secondary	False negative rate of conventional imaging compared to conventional imaging & PAI/US as measured by sensitivity of cancer detection	The anticipated improvement of cancer detection accuracy will be from current practice of 80% to 94%.	At the time of surgery (estimated to be 2 weeks)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine