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Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary

Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03262818
Enrollment
40
Registered
2017-08-25
Start date
2017-02-01
Completion date
2018-11-20
Last updated
2018-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oophorectomy

Brief 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.

Interventions

DEVICETransvaginal ultrasound

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

DEVICEUltrasound/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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure PAI/ultrasound signatures from ovaries prior to surgeryPrior 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

MeasureTime frameDescription
Characterize the tissue images with pathologic diagnosisAt 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 imagingAt 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026