This trial develops procedures for imaging tissue of the ovary in patients who are at an increased risk for ovarian cancer in order to better study ovarian disease. Transvaginal ultrasound (standard of care) is an imaging technique where sound waves are sent into the body and echoes are received by the probe to form an image. Photoacoustic imaging is an imaging technique where a handheld probe is used to take pictures of internal structures within the body. It uses short pulses of laser light to generate ultrasound waves within the body that are received by the probe to form corresponding images. Studying how these imaging techniques might work together or separately may help researchers improve the ability to detect ovarian cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04178018.
Locations matching your search criteria
United States
Missouri
Saint Louis
Siteman Cancer Center at Washington UniversityStatus: Active
Contact: Cary Lynn Siegel
Phone: 314-362-2928
PILOT STUDY OBJECTIVES:
I. To measure photoacoustic imaging (PAI)/ultrasound signature from ovaries prior to surgery.
II. To characterize the tissue images with pathologic diagnosis.
III. To refine the system and imaging algorithms based on the characteristic features of in vivo
imaging.
PRIMARY OBJECTIVE:
I. To assess the impact of co-registered PAI/ultrasound (US) on the potential reduction of benign surgeries.
SECONDARY OBJECTIVE:
I. To assess the false negative rate of both confidence interval (CI) and CI & PAI/US to ensure that CI & PAI/US diagnostic improvement in reducing benign surgeries does not sacrifice sensitivity.
EXPLORATORY STUDY OBJECTIVES:
I. To 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.
II. To determine normal changes of photoacoustic imaging parameters as well as spectral parameters across the menstrual cycle.
OUTLINE:
PILOT STUDY: Patients undergo standard of care transvaginal US, then undergo a second transvaginal US with PAI over 10-15 minutes.
MAIN STUDY: Patients undergo standard of care transvaginal US, then undergo a second transvaginal US with PAI over 10-15 minutes.
EXPLORATORY STUDY (HIGH-RISK): Patients undergo standard of care transvaginal US, then undergo a second transvaginal US with PAI over 10-15 minutes every 6 months for up to 4.5 years.
EXPLORATORY SUB-STUDY (HIGH-RISK): Patients undergo standard of care transvaginal US, then undergo a second transvaginal US with PAI over 10-15 minutes every 2 weeks (Q2W) at the follicular and luteal phases of their menstrual cycle for 3 months for a total of up to 6 US with PAI.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorCary Lynn Siegel
