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Completed

NCT Number: NCT03262818

Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary

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.

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Key information

Conditions

Oophorectomy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transvaginal ultrasound

Device

-Will be performed by US technologists at Washington University School of Medicine and read by Dr. Cary Siegel or Dr. Kathryn Robinson

Other names: Transvaginal US

Ultrasound/Photoacoustic imaging

Device

-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 names: US/PAI

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 25, 2017
Registry last updated
Nov 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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