Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary

Oophorectomy Clinical Trial

Official title:

Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03262818
• Other study ID #: 201608016
• Secondary ID: 5R01CA151570-02
• Status: Completed
• Phase: Phase 1
• Start date: February 1, 2017
• Est. completion date: November 20, 2018

Study information

• Verified date: November 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators have developed co-registered photoacoustic and ultrasound (US) imaging technique that allows the investigators to visualize tumor structure and functional changes simultaneously, which may potentially reveal early tumor angiogenesis development that is not available by US alone. The ability to detect early angiogenesis changes, as well as tumor morphology changes in the ovary, using a non-invasive imaging modality will greatly enhance the care for women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 20, 2018
• Est. primary completion date: November 19, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Referred to Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy

• Willingness to participate in the study

• Able to provide informed consent

Exclusion Criteria

• Younger than 18 years of age

• Not able to provide informed consent

Related Conditions & MeSH terms

• Oophorectomy

Intervention

Device:
• Transvaginal ultrasound
-Will be performed by US technologists at Washington University School of Medicine and read by Dr. Cary Siegel or Dr. Kathryn Robinson
• Ultrasound/Photoacoustic imaging
-The light illumination for the photoacoustic imaging system is provided by a wavelength-tunable Ti:Sapphire laser (LOTIS TII), optically pumped by an Nd:YAG laser (LOTIS TII) at 532 nm wavelength.

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
Primary	Measure PAI/ultrasound signatures from ovaries prior to surgery	-The transvaginal US will be performed by US technologists or radiologists at the Radiology Department and images will be read by one of the study radiologists either Dr. Cary Siegel or Dr. Kathryn Robinson of the Radiology Department. The reading will be categorized as normal, suspicious or highly suspicious. The scores will serve as a baseline comparison of US/PAI technique with the current clinical practice using US. Immediately after the transvaginal US, US/PAI imaging will be performed with the assistance of the US technologist or radiologist.	Prior to surgery (no more than 30 days prior to surgery)
Secondary	Characterize the tissue images with pathologic diagnosis	-The in vivo and ex vivo PAI/US images with be compared with final pathologic diagnosis.	At the time of surgery (no more than 30 days after PAI/US)
Secondary	Refine the system and imaging algorithms based on the characteristic features of in vivo imaging	-Will be used to distinguish between benign and malignant ovarian tissues. Student t-test will be used for statistical significant test of each feature obtained from malignant and benign ovaries. Those features with p value less than 0.05 will be used as a predictor.	At the time of surgery (no more than 30 days after PAI/US)

External Links

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