310 Participants Needed

Ultrasound + Photoacoustic Imaging for Ovarian Health

CL
Overseen ByCary L Siegel, M.D.
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial is testing a new imaging technique that uses light and sound to help doctors see inside the body. It aims to help high-risk ovarian cancer patients avoid unnecessary surgeries while still detecting cancer early.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Ultrasound + Photoacoustic Imaging for Ovarian Health?

Research shows that combining photoacoustic imaging (which uses laser light to create images based on tissue blood supply) with ultrasound can help detect ovarian cancer earlier and distinguish between benign and malignant ovarian masses. This combination has shown promise in improving early diagnosis, which is crucial since early-stage detection significantly increases the chances of successful treatment.12345

Is ultrasound and photoacoustic imaging safe for human use?

The studies show that the laser energy used in photoacoustic imaging is below the safety limits set by the American National Standards Institute, suggesting it is safe for human use. Additionally, the imaging system has been tested on human ovarian tissues and healthy volunteers without reported safety issues.16789

How does the ultrasound and photoacoustic imaging treatment for ovarian health differ from other treatments?

This treatment combines ultrasound with photoacoustic imaging, a novel technique that uses laser-induced sound waves to create detailed images of tissue. Unlike traditional imaging methods, it provides both anatomical and functional information, which can help in early detection and differentiation of ovarian cancer from benign conditions.2341011

Research Team

CL

Cary L Siegel, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults who may carry certain genetic mutations linked to ovarian cancer (like BRCA1/2) and are referred for surgery that includes removal of at least one ovary. Participants should be willing to be monitored for 1-2 years before deciding on preventive ovary removal.

Inclusion Criteria

My ovarian cancer has a harmful mutation in a specific gene.
I am willing to be monitored for 1-2 years before deciding on preventive ovary removal.
I am willing and able to give my consent to participate in the study.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Baseline transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging for all participants enrolled

1 day
1 visit (in-person)

Surgical Procedure and Imaging

Once the surgeon has surgically removed the ovary(ies), they will be imaged with the photoacoustic imaging/ultrasound

At the time of surgery (estimated to be 2 weeks)

Exploratory Imaging Follow-up

For high-risk participants, transvaginal ultrasound and photoacoustic imaging will be performed at 6, 12, 18, 24 months, and at the time of surgery

24 months
Multiple visits (in-person)

Menstrual Cycle Imaging

For a subset of high-risk participants, imaging will be performed every 2 weeks at follicular and luteal phases for 3 months

3 months
Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4.5 years

Treatment Details

Interventions

  • Photoacoustic imaging
  • Ultrasound
Trial OverviewThe study tests if photoacoustic imaging, combined with ultrasound, can reduce unnecessary surgeries while still effectively detecting ovarian cancer, especially in early stages among high-risk patients.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Transvaginal photoacoustic imaging/ultrasoundExperimental Treatment2 Interventions
* Baseline transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging for all participants enrolled * Once the surgeon has surgically removed the ovary(ies), they will be imaged with the photoacoustic imaging/ultrasound * For the exploratory outcome measure for high risk participants (approximately 50 participants), the transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging will be performed additionally at 6 months, 12 months, 18 months, 24 months, and at the time of surgery * For the exploratory outcome measure for high risk participants (approximately 10 participants), the transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging will be performed additionally every 2 weeks at follicular phase and at the luteal phase for 3 months

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Photoacoustic imaging (PAT) combined with ultrasound shows promise in detecting ovarian cancer by measuring total hemoglobin concentration and blood oxygen saturation in ovarian lesions, which are crucial for accurate diagnosis.
The study presents a standardized transvaginal imaging protocol for ovarian cancer that could enhance consistency in clinical applications and improve the detection of cancerous lesions, potentially reducing unnecessary surgeries for benign conditions.
A Coregistered Ultrasound and Photoacoustic Imaging Protocol for the Transvaginal Imaging of Ovarian Lesions.Nie, H., Luo, H., Chen, L., et al.[2023]
A new 3-D ultrasound and photoacoustic imaging system has been developed, which can quickly produce detailed images of ovarian tissue, potentially improving early detection of ovarian cancer.
The system shows excellent alignment between ultrasound and photoacoustic images, revealing important differences in optical properties of ovarian tissue, such as strong absorption in highly vascularized areas, which could aid in understanding ovarian cancer.
Coregistered three-dimensional ultrasound and photoacoustic imaging system for ovarian tissue characterization.Aguirre, A., Guo, P., Gamelin, J., et al.[2023]
The OPUS system combines optoacoustic imaging with ultrasound technology, allowing for enhanced breast cancer detection by providing additional information about tissue absorption without major modifications to existing ultrasound equipment.
This system enables the generation of 2D and 3D images of optical absorption in tissues, which can be quantitatively analyzed to assess absorber concentrations, improving diagnostic capabilities in medical imaging.
Combined optoacoustic/ultrasound system for tomographic absorption measurements: possibilities and limitations.Haisch, C., Eilert-Zell, K., Vogel, MM., et al.[2016]

References

A Coregistered Ultrasound and Photoacoustic Imaging Protocol for the Transvaginal Imaging of Ovarian Lesions. [2023]
Coregistered three-dimensional ultrasound and photoacoustic imaging system for ovarian tissue characterization. [2023]
Combined optoacoustic/ultrasound system for tomographic absorption measurements: possibilities and limitations. [2016]
A review of co-registered transvaginal photoacoustic and ultrasound imaging for ovarian cancer diagnosis. [2022]
Characterization of adnexal lesions using photoacoustic imaging to improve sonographic O-RADS risk assessment. [2023]
Design of optimal light delivery system for co-registered transvaginal ultrasound and photoacoustic imaging of ovarian tissue. [2020]
Optoacoustic Breast Imaging: Imaging-Pathology Correlation of Optoacoustic Features in Benign and Malignant Breast Masses. [2019]
Combined Pulse-Echo Ultrasound and Multispectral Optoacoustic Tomography With a Multi-Segment Detector Array. [2018]
Co-registered pulse-echo/photoacoustic transvaginal probe for real time imaging of ovarian tissue. [2021]
Multispectral optoacoustic tomography of the human breast: characterisation of healthy tissue and malignant lesions using a hybrid ultrasound-optoacoustic approach. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Development of Multispectral Optoacoustic Tomography as a Clinically Translatable Modality for Cancer Imaging. [2023]