Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary
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|ClinicalTrials.gov Identifier: NCT03262818|
Recruitment Status : Completed
First Posted : August 25, 2017
Last Update Posted : November 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Oophorectomy||Device: Transvaginal ultrasound Device: Ultrasound/Photoacoustic imaging||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary|
|Actual Study Start Date :||February 1, 2017|
|Actual Primary Completion Date :||November 19, 2018|
|Actual Study Completion Date :||November 20, 2018|
Experimental: Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging
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
Other Name: Transvaginal US
Device: 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.
Other Name: US/PAI
- Measure PAI/ultrasound signatures from ovaries prior to surgery [ Time Frame: Prior to surgery (no more than 30 days 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.
- Characterize the tissue images with pathologic diagnosis [ Time Frame: At the time of surgery (no more than 30 days after PAI/US) ]-The in vivo and ex vivo PAI/US images with be compared with final pathologic diagnosis.
- Refine the system and imaging algorithms based on the characteristic features of in vivo imaging [ Time Frame: At the time of surgery (no more than 30 days after PAI/US) ]-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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262818
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Cary L Siegel, M.D.||Washington University School of Medicine|