400 Participants Needed

Photoacoustic Imaging for Breast Cancer

Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Roswell Park Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies photoacoustic imaging of the breast in patients with breast cancer and healthy subjects. Dense breasts typically reduce the sensitivity of a mammography and also is associated with a higher risk of breast cancer. Photoacoustic tomography combines light and sound to provide more information about breast tissue.

Will I have to stop taking my current medications?

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

Is photoacoustic imaging safe for humans?

Photoacoustic imaging, used for breast cancer and other conditions, is generally considered safe for humans. It is a non-invasive technique that does not use ionizing radiation, which means it doesn't expose patients to harmful radiation. Clinical studies have been conducted, and the technology is being translated into clinical use, indicating a favorable safety profile.12345

How does photoacoustic imaging differ from other breast cancer treatments?

Photoacoustic imaging is unique because it combines laser light and ultrasound to create detailed images of breast tissue, allowing for non-invasive detection of cancer by mapping blood vessel growth and oxygen levels in tumors. This method offers higher resolution than traditional imaging techniques and can be particularly useful for women with dense breast tissue, where standard mammograms may be less effective.14567

What data supports the effectiveness of the treatment Photoacoustic Imaging for Breast Cancer?

Recent studies show that photoacoustic imaging (PAI) can improve breast cancer diagnosis by enhancing the contrast between blood vessels and surrounding tissue, helping to better identify suspicious areas. Additionally, PAI has been shown to provide complementary information to standard ultrasound, potentially improving the accuracy of breast cancer screening.5891011

Who Is on the Research Team?

EB

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).
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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?
1Treatment groups
Experimental Treatment
Group I: Diagnostic (photoacoustic imaging of the breast)Experimental Treatment1 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.

Find a Clinic Near You

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

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.
A review of optical breast imaging: Multi-modality systems for breast cancer diagnosis.Zhu, Q., Poplack, S.[2021]
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.
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 (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.
Assessment of the added value of the Twente Photoacoustic Mammoscope in breast cancer diagnosis.Hilgerink, MP., Hummel, MJ., Manohar, S., et al.[2021]

Citations

A review of optical breast imaging: Multi-modality systems for breast cancer diagnosis. [2021]
Real-time photoacoustic and ultrasound imaging: a simple solution for clinical ultrasound systems with linear arrays. [2022]
Assessment of the added value of the Twente Photoacoustic Mammoscope in breast cancer diagnosis. [2021]
Downgrading and Upgrading Gray-Scale Ultrasound BI-RADS Categories of Benign and Malignant Masses With Optoacoustics: A Pilot Study. [2019]
Photoacoustic breast tomography prototypes with reported human applications. [2020]
Current and future trends in photoacoustic breast imaging. [2020]
Optoacoustic Breast Imaging: Imaging-Pathology Correlation of Optoacoustic Features in Benign and Malignant Breast Masses. [2019]
Photoacoustic clinical imaging. [2023]
Photoacoustic Imaging in Oncology: Translational Preclinical and Early Clinical Experience. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Photoacoustic imaging of breast cancer: a mini review of system design and image features. [2020]
Imaging of tumor vasculature using Twente photoacoustic systems. [2009]
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