Ultrasound + Photoacoustic Imaging for Ovarian Health

Overseen by Cary L Siegel, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Washington University School of Medicine

Disqualifiers: Male, Younger than 18, others

No Placebo Group

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. ^{1 2 3 4 5}

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. ^{4 6 7 8 9}

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. ^{1 3 5 10 11}

Research Team

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.

Trial 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 (Imaging)
• Ultrasound (Imaging)

Trial Overview The 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

Group I: Transvaginal photoacoustic imaging/ultrasound Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

David H. Perlmutter

Washington University School of Medicine

Chief Executive Officer since 2015

MD from Washington University School of Medicine

Paul Scheel

Washington University School of Medicine

Chief Medical Officer since 2022

MD from Washington University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

In a study of 68 women with ovarian/adnexal lesions, incorporating photoacoustic imaging (PAI) significantly improved the diagnostic performance of the O-RADS system, achieving an impressive area under the curve (AUC) of 0.970 for predicting malignancy.

Malignant lesions showed higher relative total hemoglobin concentration (rHbT) and lower blood oxygenation saturation (%sO2), indicating that these PAI-derived metrics are important predictors of malignancy when combined with traditional markers like CA125 and O-RADS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of adnexal lesions using photoacoustic imaging to improve sonographic O-RADS risk assessment. Zhu, Q., Luo, H., Middleton, WD., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 hand-held transvaginal probe for co-registered photoacoustic and ultrasound imaging was developed, allowing for effective imaging of ovarian tissues at depths of up to 30 mm, while maintaining a safe laser fluence below the maximum permissible exposure.

The probe successfully distinguished between benign and malignant ovarian tissues by revealing different vascular patterns, indicating its potential for clinical use in diagnosing ovarian conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of optimal light delivery system for co-registered transvaginal ultrasound and photoacoustic imaging of ovarian tissue. Salehi, HS., Kumavor, PD., Li, H., et al.[2020]

In a study of 92 breast masses assessed using optoacoustic ultrasound, higher scores for external features (like hemoglobin levels and vessel abnormalities) were significantly associated with malignant masses, indicating a strong predictive value for cancer (p < 0.0001).

The findings suggest that optoacoustic ultrasound can effectively differentiate between benign and malignant breast masses, particularly by focusing on external features, which may help address challenges in distinguishing between the two based solely on morphology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optoacoustic Breast Imaging: Imaging-Pathology Correlation of Optoacoustic Features in Benign and Malignant Breast Masses. Butler, R., Lavin, PT., Tucker, FL., et al.[2019]

A new multi-segment detector array has been developed that effectively combines ultrasonography and optoacoustic tomography, allowing for simultaneous imaging of anatomical structures and functional information about blood oxygenation.

This innovative approach has been successfully tested in real-time with a healthy volunteer, demonstrating its potential for high-quality imaging in medical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Pulse-Echo Ultrasound and Multispectral Optoacoustic Tomography With a Multi-Segment Detector Array. Mercep, E., Dean-Ben, XL., Razansky, D.[2018]

Multispectral optoacoustic tomography (MSOT) is a promising imaging technique that can produce high-contrast, high-resolution images at depths of up to 5 cm, which could enhance medical diagnostics.

For MSOT to be effectively used in clinical settings, it needs improvements in probe design and data acquisition systems, as well as more user-friendly real-time visualization tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Multispectral Optoacoustic Tomography as a Clinically Translatable Modality for Cancer Imaging. MacCuaig, WM., Jones, MA., Abeyakoon, O., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

A review of co-registered transvaginal photoacoustic and ultrasound imaging for ovarian cancer diagnosis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Characterization of adnexal lesions using photoacoustic imaging to improve sonographic O-RADS risk assessment. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Coregistered three-dimensional ultrasound and photoacoustic imaging system for ovarian tissue characterization. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A Coregistered Ultrasound and Photoacoustic Imaging Protocol for the Transvaginal Imaging of Ovarian Lesions. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Combined optoacoustic/ultrasound system for tomographic absorption measurements: possibilities and limitations. [2016]

6. Germany pubmed.ncbi.nlm.nih.gov

Design of optimal light delivery system for co-registered transvaginal ultrasound and photoacoustic imaging of ovarian tissue. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Optoacoustic Breast Imaging: Imaging-Pathology Correlation of Optoacoustic Features in Benign and Malignant Breast Masses. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Combined Pulse-Echo Ultrasound and Multispectral Optoacoustic Tomography With a Multi-Segment Detector Array. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

Co-registered pulse-echo/photoacoustic transvaginal probe for real time imaging of ovarian tissue. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Multispectral optoacoustic tomography of the human breast: characterisation of healthy tissue and malignant lesions using a hybrid ultrasound-optoacoustic approach. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Development of Multispectral Optoacoustic Tomography as a Clinically Translatable Modality for Cancer Imaging. [2023]