Photoacoustic Imaging for Breast Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Roswell Park Cancer Institute
Disqualifiers: Pregnancy, Breast implants, Lumpectomy, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
56789How 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.
5691011Eligibility Criteria
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 am under the age of 18.
I have had a lumpectomy.
I understand there's no direct benefit from the study and I speak English.
+4 more
Trial Timeline
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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Roswell Park Cancer InstituteBuffalo, NY
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Who Is Running the Clinical Trial?
Roswell Park Cancer InstituteLead Sponsor
Susan G. Komen Breast Cancer FoundationCollaborator
References
A review of optical breast imaging: Multi-modality systems for breast cancer diagnosis. [2021]This review of optical breast imaging describes basic physical and system principles and summarizes technological evolution with a focus on multi-modality platforms and recent clinical trial results. Ultrasound-guided diffuse optical tomography and co-registered ultrasound and photoacoustic imaging systems are emphasized as models of state of the art optical technology that are most conducive to clinical translation.
Real-time photoacoustic and ultrasound imaging: a simple solution for clinical ultrasound systems with linear arrays. [2022]Recent clinical studies have demonstrated that photoacoustic imaging (PAI) provides important diagnostic information during a routine breast exam for cancer. PAI enhances contrast between blood vessels and background tissue, which can help characterize suspicious lesions. However, most PAI systems are either not compatible with commercial ultrasound systems or inefficiently deliver light to the region of interest, effectively reducing the sensitivity of the technique. To address and potentially overcome these limitations, we developed an accessory for a standard linear ultrasound array that optimizes light delivery for PAI. The photoacoustic enabling device (PED) exploits an optically transparent acoustic reflector to help direct laser illumination to the region of interest. This study compares the PED with standard fiber bundle illumination in scattering and non-scattering media. In scattering media with the same incident fluence, the PED enhanced the photoacoustic signal by 18 dB at a depth of 5 mm and 6 dB at a depth of 20 mm. To demonstrate in vivo feasibility, we also used the device to image a mouse with a pancreatic tumor. The PED identified blood vessels at the periphery of the tumor, suggesting that PAI provides complementary contrast to standard pulse echo ultrasound. The PED is a simple and inexpensive solution that facilitates the translation of PAI technology to the clinic for routine screening of breast cancer.
Assessment of the added value of the Twente Photoacoustic Mammoscope in breast cancer diagnosis. [2021]Photoacoustic (PA) imaging is a recently developed breast cancer imaging technique. In order to enhance successful clinical implementation, we quantified the potential clinical value of different scenarios incorporating PA imaging by means of multi-criteria analysis. From this analysis, the most promising area of application for PA imaging in breast cancer diagnosis is determined, and recommendations are provided to optimize the design of PA imaging.
Downgrading and Upgrading Gray-Scale Ultrasound BI-RADS Categories of Benign and Malignant Masses With Optoacoustics: A Pilot Study. [2019]False-positive findings remain challenging in breast imaging. This study investigates the incremental value of optoacoustic imaging in improving BI-RADS categorization of breast masses at ultrasound.
Photoacoustic breast tomography prototypes with reported human applications. [2020]Photoacoustic breast tomography could provide optical molecular imaging with near-infrared light at sonographic image resolution by utilizing the photoacoustic effect. This review summarizes reports about current prototypes that were applied in vivo in humans.
Current and future trends in photoacoustic breast imaging. [2020]Non-invasive detection of breast cancer has been regarded as the holy grail of applications for photoacoustic (optoacoustic) imaging right from the early days of re-discovery of the method. Two-and-a-half decades later we report on the state-of-the-art in photoacoustic breast imaging technology and clinical studies. Even within the single application of breast imaging, we find imagers with various measurement geometries, ultrasound detection characteristics, illumination schemes, and image reconstruction strategies. We first analyze the implications on performance of a few of these design choices in a generic imaging system, before going into detailed descriptions of the imagers. Per imaging system we present highlights of patient studies, which barring a couple are mostly in the nature of technology demonstrations and proof-of-principle studies. We close this work with a discussion on several aspects that may turn out to be crucial for the future clinical translation of the method.
Optoacoustic Breast Imaging: Imaging-Pathology Correlation of Optoacoustic Features in Benign and Malignant Breast Masses. [2019]Optoacoustic ultrasound breast imaging is a fused anatomic and functional modality that shows morphologic features, as well as hemoglobin amount and relative oxygenation within and around breast masses. The purpose of this study is to investigate the positive predictive value (PPV) of optoacoustic ultrasound features in benign and malignant masses.
Photoacoustic clinical imaging. [2023]Photoacoustic is an emerging biomedical imaging modality, which allows imaging optical absorbers in the tissue by acoustic detectors (light in - sound out). Such a technique has an immense potential for clinical translation since it allows high resolution, sufficient imaging depth, with diverse endogenous and exogenous contrast, and is free from ionizing radiation. In recent years, tremendous developments in both the instrumentation and imaging agents have been achieved. These opened avenues for clinical imaging of various sites allowed applications such as brain functional imaging, breast cancer screening, diagnosis of psoriasis and skin lesions, biopsy and surgery guidance, the guidance of tumor therapies at the reproductive and urological systems, as well as imaging tumor metastases at the sentinel lymph nodes. Here we survey the various clinical and pre-clinical literature and discuss the potential applications and hurdles that still need to be overcome.
Photoacoustic Imaging in Oncology: Translational Preclinical and Early Clinical Experience. [2022]Photoacoustic imaging has evolved into a clinically translatable platform with the potential to complement existing imaging techniques for the management of cancer, including detection, characterization, prognosis, and treatment monitoring. In photoacoustic imaging, tissue is optically excited to produce ultrasonographic images that represent a spatial map of optical absorption of endogenous constituents such as hemoglobin, fat, melanin, and water or exogenous contrast agents such as dyes and nanoparticles. It can therefore provide functional and molecular information that allows noninvasive soft-tissue characterization. Photoacoustic imaging has matured over the years and is currently being translated into the clinic with various clinical studies underway. In this review, the current state of photoacoustic imaging is presented, including techniques and instrumentation, followed by a discussion of potential clinical applications of this technique for the detection and management of cancer. (©) RSNA, 2016.
Photoacoustic imaging of breast cancer: a mini review of system design and image features. [2020]Breast cancer is one of the leading causes for cancer related deaths in women, and early detection is extremely important to improve survival rates. Currently, x-ray mammogram is the only modality for mass screening of asymptomatic women. However, it has decreased sensitivity in radiographically dense breasts, which is also associated with a higher risk for breast cancer. Photoacoustic (PA) imaging is an emerging modality that enables deep tissue imaging of optical contrast at ultrasonically defined spatial resolution, which is much higher than that can be achieved in purely optical imaging modalities. Because of high optical absorption from hemoglobin molecules, PA imaging can map out hemo distribution and dynamics in breast tissue and identify malignant lesions based on tumor associated angiogenesis and hypoxia. We review various PA breast imaging systems proposed over the past few years and summarize the PA features of breast cancer identified in these systems.
Imaging of tumor vasculature using Twente photoacoustic systems. [2009]Photoacoustic imaging is a hybrid imaging modality based on the detection of acoustic waves generated by the absorption of short laser pulses in biological tissue. It combines the advantages of excellent contrast achieved in optical techniques with the high resolution of ultrasound imaging. In this article we present a review of the work done at the University of Twente to image tumor angiogenesis in vivo using this technique. We start with a description and the technical details of the different photoacoustic systems developed in our laboratory, with their validation on phantoms. We then discuss small-animal studies with results of serial imaging of angiogenesis over a 10-day period at the site of tumor induction in a rat. Further, we present clinical results using a photoacoustic mammoscope of breast cancer imaging based on angiogenesis-driven optical absorption contrast.