Photoacoustic Imaging for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Pregnancy, Breast implants, Lumpectomy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method called photoacoustic imaging to better understand breast tissue. It aims to improve breast cancer detection accuracy, especially in dense breasts, by combining light and sound. Women with suspicious or confirmed breast cancer masses who have had or will have an MRI (a scan using magnets and radio waves to take pictures of the body's interior) might be eligible to participate. Participants will undergo imaging sessions lasting about 30 minutes each. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance breast cancer detection methods.

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 photoacoustic imaging is safe for breast cancer patients and healthy subjects?

Research has shown that photoacoustic imaging is generally safe for people. This technique uses light and sound to create detailed pictures of breast tissue and is non-invasive, meaning it doesn't require surgery or use radiation.

Previous studies report that patients tolerate photoacoustic imaging well, with no major side effects. Because it doesn't involve harmful exposure, it can be safely used multiple times if needed.

Overall, existing research supports the safety of photoacoustic imaging for detecting and diagnosing breast cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about photoacoustic imaging for breast cancer because it offers a unique way to visualize tumors. Unlike traditional imaging methods like mammography or ultrasound, photoacoustic imaging combines light and sound to create detailed images of breast tissue, potentially improving the accuracy of cancer detection. This technique is non-invasive and could reduce the need for multiple diagnostic procedures, making it a promising advancement in early detection and monitoring of breast cancer.

What evidence suggests that photoacoustic imaging is effective for breast cancer?

Research has shown that photoacoustic imaging, which participants in this trial will undergo, is a promising method for detecting breast cancer. This technique uses light and sound to create clear images of breast tissue, aiding in tumor detection. Studies have found it effective even in dense breast tissue, where traditional mammograms often struggle. The imaging reveals blood vessel patterns near tumors, helping doctors identify tumor edges more accurately. Additionally, photoacoustic imaging avoids harmful radiation, making it safer for repeated use. Overall, early evidence suggests it could be highly effective for early breast cancer diagnosis. ^{1 2 6 7 8}

Who Is on the Research Team?

Ermelinda Bonaccio

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for women with suspected or confirmed breast cancer who have not had the mass surgically removed and have undergone or will undergo an MRI. It excludes non-English speakers, prisoners, minors, pregnant women (to avoid unknown risks), those with recent breast implants, and adults unable to consent.

Inclusion Criteria

I have a breast mass that hasn't been removed and will/have had a breast MRI.

Exclusion Criteria

I have had a lumpectomy.

I understand there's no direct benefit from the study and I speak English.

Pregnant women (there are no known risks to these procedures, but any unforeseen risks are as yet undetermined, so pregnant women will be excluded by means of a verbal confirmation at time of screening).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo photoacoustic imaging of the breast over 30 minutes. Imaging may repeat for a total of 10 studies, each on a separate day.

10 days

Up to 10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Photoacoustic Imaging

Trial Overview The study is testing photoacoustic imaging on the breast tissue of both healthy subjects and patients with breast cancer. This technique combines light and sound to potentially improve detection in dense breasts where mammography may be less sensitive.

How Is the Trial Designed?

Group I: Diagnostic (photoacoustic imaging of the breast) Experimental Treatment 1 Intervention

Participants undergo photoacoustic imaging of the breast over 30 minutes. At subject's discretion, imaging may repeat for a total of 10 studies, each in a separate day.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Susan G. Komen Breast Cancer Foundation

Collaborator

Trials

68

Recruited

220,000+

Published Research Related to This Trial

Photoacoustic imaging is a promising technique that combines light and sound to visualize tissues, offering high resolution and depth without using harmful ionizing radiation, making it safe for clinical use.

Recent advancements in technology and imaging agents have expanded the potential applications of photoacoustic imaging, including brain imaging, cancer detection, and surgical guidance, although challenges remain for widespread clinical adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photoacoustic clinical imaging. Steinberg, I., Huland, DM., Vermesh, O., et al.[2023]

The photoacoustic enabling device (PED) significantly improves photoacoustic imaging (PAI) by enhancing the signal strength, achieving an 18 dB increase at 5 mm depth and 6 dB at 20 mm depth in scattering media, making it more effective for detecting cancerous lesions during breast exams.

The PED was successfully tested in vivo, demonstrating its ability to identify blood vessels around a pancreatic tumor, indicating its potential to complement standard ultrasound techniques in cancer diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time photoacoustic and ultrasound imaging: a simple solution for clinical ultrasound systems with linear arrays. Montilla, LG., Olafsson, R., Bauer, DR., et al.[2022]

Photoacoustic imaging effectively combines the high contrast of optical techniques with the resolution of ultrasound, making it a powerful tool for visualizing tumor angiogenesis in biological tissues.

In studies conducted at the University of Twente, this technique successfully tracked angiogenesis in tumors over a 10-day period in rats and demonstrated promising results in clinical breast cancer imaging, highlighting its potential for real-time monitoring of tumor development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of tumor vasculature using Twente photoacoustic systems. Jose, J., Manohar, S., Kolkman, RG., et al.[2009]

Photoacoustic (PA) imaging is identified as a promising non-invasive and low-cost alternative for early breast cancer diagnosis, potentially replacing traditional x-ray mammography and ultrasonography.

While PA imaging is favored for its safety and cost-effectiveness, experts suggest that improvements in diagnostic performance should focus on enhancing the reconstruction algorithm and detector technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the added value of the Twente Photoacoustic Mammoscope in breast cancer diagnosis. Hilgerink, MP., Hummel, MJ., Manohar, S., et al.[2021]

Photoacoustic imaging is a promising new technique that can enhance cancer management by providing detailed images that show the distribution of important substances in tissues, such as hemoglobin and fat, which can help in detecting and monitoring tumors.

This imaging method is noninvasive and offers both functional and molecular insights, making it a valuable complement to existing imaging techniques in clinical settings, with various studies currently exploring its applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photoacoustic Imaging in Oncology: Translational Preclinical and Early Clinical Experience. Valluru, KS., Wilson, KE., Willmann, JK.[2022]

Photoacoustic (PA) imaging offers a promising alternative to traditional x-ray mammograms for breast cancer screening, especially in women with dense breast tissue where mammograms are less effective.

PA imaging can detect malignant lesions by mapping blood vessel distribution and oxygen levels in breast tissue, providing higher spatial resolution and potentially improving early detection of breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photoacoustic imaging of breast cancer: a mini review of system design and image features. Nyayapathi, N., Xia, J.[2020]

Photoacoustic breast tomography has shown promising results in detecting breast cancer, identifying 85% of cancers in a study involving five prototypes tested in humans.

This innovative imaging technique combines optical and ultrasound technologies, providing high-resolution images without radiation, and should be further developed for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photoacoustic breast tomography prototypes with reported human applications. Menke, J.[2020]

Photoacoustic imaging has advanced significantly over the past 25 years, showing promise for non-invasive breast cancer detection through various imaging technologies and strategies.

Most clinical studies conducted so far are primarily proof-of-principle demonstrations, indicating that while the technology is promising, further research is needed for its full clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future trends in photoacoustic breast imaging. Manohar, S., Dantuma, M.[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]

The review highlights the advancements in optical breast imaging technologies, particularly focusing on ultrasound-guided diffuse optical tomography and combined ultrasound and photoacoustic imaging systems, which are promising for clinical use.

These multi-modality platforms represent the latest developments in optical imaging, potentially improving breast cancer detection and diagnosis through enhanced imaging capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of optical breast imaging: Multi-modality systems for breast cancer diagnosis. Zhu, Q., Poplack, S.[2021]

Optoacoustic ultrasound significantly improved the categorization of breast masses, downgrading 41.7% of benign or stable BI-RADS category 3 masses to category 2, indicating a potential reduction in unnecessary biopsies.

The technique also upgraded 75.0% of malignant masses classified as BI-RADS categories 4A, 4B, 4C, or 5, enhancing the accuracy of identifying serious conditions compared to traditional gray-scale ultrasound.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Downgrading and Upgrading Gray-Scale Ultrasound BI-RADS Categories of Benign and Malignant Masses With Optoacoustics: A Pilot Study. Neuschler, EI., Lavin, PT., Tucker, FL., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7005545/

Photoacoustic imaging of breast cancer: a mini review of ... Photoacoustic (PA) imaging is an emerging modality that enables deep tissue imaging of optical contrast at ultrasonically defined spatial resolution.

2. mdpi.com mdpi.com/1424-8220/25/15/4812

Advances in Photoacoustic Imaging of Breast Cancer Compared with conventional optical imaging, PAI effectively overcomes the resolution degradation caused by tissue scattering, achieving high resolution and ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/VIW.20250067

Photoacoustic integrated multimodal imaging for breast ... The PA images reveal tumor-associated vasculature tapering near the tumor center, aiding in the precise assessment of tumor boundaries and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213597924000235

An analysis of intratumoral and peritumoral radiomics This study aims to assess the efficacy of PA imaging in breast cancer radiomics, focusing on the impact of peritumoral region size on radiomic model accuracy.

5. science.org science.org/doi/10.1126/sciadv.adz2046

High-speed photoacoustic and ultrasonic computed ... This technology shows strong potential for early breast tumor diagnosis, offering enhanced accuracy without the need for ionizing radiation, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03897270

Photoacoustic Imaging of the Breast in Patients With ... This trial studies photoacoustic imaging of the breast in patients with breast cancer and healthy subjects. Dense breasts typically reduce the sensitivity of a ...

7. nature.com nature.com/articles/s41598-024-65114-0

Ultrasound-guided photoacoustic (US-PA) tomography of ... In this pilot study, we investigated the utility of handheld ultrasound-guided photoacoustic (US-PA) imaging probe for analyzing ex-vivo ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2213597918300442

Current and future trends in photoacoustic breast imaging These studies re-confirm the potential and promise of the photoacoustic method in detection and diagnosis of breast cancer.