Ultrasound + Photoacoustic Imaging for Ovarian Health

Recruiting at 1 trial location

Overseen By Cary L Siegel, M.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Male, Younger than 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

310 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new imaging method, called photoacoustic imaging, can help doctors avoid unnecessary surgeries for ovarian conditions while still accurately detecting cancer. By combining photoacoustic imaging with ultrasound (also known as sonography), researchers aim to catch ovarian cancer early, especially in individuals at high risk. Suitable candidates for this trial include those needing surgery involving one or both ovaries and having a genetic mutation linked to ovarian cancer. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance early cancer detection.

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 prior data suggests that this photoacoustic imaging/ultrasound technique is safe for ovarian health?

Research shows that ultrasound has been safely used in medical imaging for many years. Studies have found no evidence of harm from its use, even in sensitive areas like pregnancy care. Ultrasound, a well-known tool that uses low-power sound waves, carries no known risks.

Photoacoustic imaging, a newer method, combines light and sound to create detailed images. It helps doctors see tissue structures and gather important information. Current studies on photoacoustic imaging are promising, but detailed safety data remain limited. Early findings suggest it could improve cancer diagnosis without any safety issues.

In summary, ultrasound is known to be safe, while photoacoustic imaging is still under study, with no major safety concerns reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of photoacoustic imaging combined with ultrasound for assessing ovarian health because it offers a new way to visualize and understand the condition of the ovaries. Unlike standard transvaginal ultrasounds, which primarily use sound waves to create images, photoacoustic imaging adds a layer of detail by using laser-induced ultrasound to provide insights into tissue composition and blood oxygenation. This dual approach could potentially allow for earlier detection and better characterization of ovarian issues, which is something current methods struggle to achieve. By enhancing the detail and information obtained from imaging, this technique could lead to more precise monitoring and treatment strategies for individuals at high risk.

What evidence suggests that the photoacoustic imaging/ultrasound technique is effective for ovarian health?

This trial will evaluate the combination of photoacoustic imaging and ultrasound for ovarian health. Studies have shown that combining photoacoustic imaging with ultrasound holds great promise for early detection of ovarian cancer. This technique can accurately differentiate between cancerous and non-cancerous ovarian growths, with a high success rate. Photoacoustic imaging can also detect higher levels of hemoglobin, a sign of invasive ovarian cancers, aiding in their identification. Ultrasound alone is already effective in identifying ovarian issues, with some studies showing up to 97.2% accuracy. When combined, these imaging methods offer a powerful way to diagnose ovarian health problems, potentially reducing unnecessary surgeries while still effectively detecting cancer. Participants in this trial will undergo both imaging methods to assess their effectiveness in a clinical setting. ^{1 4 5 6 7}

Who Is on the Research Team?

Cary L Siegel, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Photoacoustic imaging
• Ultrasound

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.

How Is the Trial Designed?

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined optoacoustic/ultrasound system for tomographic absorption measurements: possibilities and limitations. Haisch, C., Eilert-Zell, K., Vogel, MM., et al.[2016]

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coregistered three-dimensional ultrasound and photoacoustic imaging system for ovarian tissue characterization. Aguirre, A., Guo, P., Gamelin, J., et al.[2023]

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]

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]

Early detection of ovarian cancer significantly increases the chances of successful treatment, with cure rates of 70%-90% at localized stages compared to 20% or less at later stages.

Photoacoustic imaging (PAI), when combined with transvaginal ultrasound, shows potential for improving early diagnosis of ovarian cancer by providing detailed imaging of tissue microvasculature, which is crucial for identifying malignant masses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Multispectral optoacoustic tomography (MSOT) is a promising imaging technique that can differentiate between invasive breast cancer and healthy tissue by measuring haemoglobin levels and oxygen saturation, with a study involving 13 participants (6 healthy volunteers and 7 patients with breast cancer).

The study found that MSOT provided stable and reproducible signals, indicating its potential for real-time molecular imaging and aiding in the identification of breast cancer pathology, particularly showing increased perfusion in invasive carcinoma compared to healthy tissue.

NCBI (Pubmed)

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. Becker, A., Masthoff, M., Claussen, J., et al.[2020]

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]

A new imaging probe was developed that combines pulse-echo ultrasound and photoacoustic imaging, allowing for real-time visualization of tissues.

The probe showed promising results in imaging blood flow and human ovarian tissue, indicating its potential for improving ovarian tissue characterization in live patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-registered pulse-echo/photoacoustic transvaginal probe for real time imaging of ovarian tissue. Kumavor, PD., Alqasemi, U., Tavakoli, B., et al.[2021]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10663056/

A Coregistered Ultrasound and Photoacoustic Imaging ... Combined with coregistered ultrasound (US), PAT has demonstrated great potential for detecting ovarian cancers and for accurately diagnosing ovarian lesions for ...

2. reporter.nih.gov reporter.nih.gov/project-details/10756093

Coregistered Photoacoustic and Ultrasound Imaging for Ovarian ... The new imaging device will also be used to screen a small group of women who have increased risk of ovarian cancer to determine its effectiveness on early ...

3. opg.optica.org opg.optica.org/boe/abstract.cfm?uri=boe-12-4-2250

Photoacoustic tomography reconstruction using lag-based ... DMAS-LAG-CF can improve cancer diagnosis with an AUC of 0.91 for distinguishing malignant vs. benign ovarian lesions when mean and skewness are used as ...

4. nature.com nature.com/articles/s41598-019-50743-7

Optical Resolution Photoacoustic Microscopy of Ovary and ... This manuscript reports the first study of OR-PAM for imaging and quantification of microvascular components of human ovary and fallopian tube.

5. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.2018180666

Evaluation of Ovarian Cancer: Initial Application ... The coregistered photoacoustic and US technique showed higher relative total hemoglobin concentration in invasive epithelial ovarian cancers ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04178018

Transvaginal Ultrasound and Photoacoustic Imaging of Ovary This study is being conducted to validate if photoacoustic imaging potentially reduces benign surgeries without compromising cancer detection sensitivity. The ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10790789/

Mini review of photoacoustic clinical imaging: a noninvasive ... Photoacoustic (PA) imaging is an emerging medical imaging technique that enables detailed visualization of tissue structures and functional information.