Can the Clinical Utility of iBreastExam, a Novel Device, Aid in Optimizing Breast Cancer Diagnosis? A Systematic Review

Bhimani, Fardeen; Zhang, Janice; Shah, Lamisha; McEvoy, Maureen; Gupta, Anjuli; Pastoriza, Jessica; Shihabi, Areej; Feldman, Sheldon

doi:10.1200/go.23.00149

Cited by 3 publications

(1 citation statement)

References 36 publications

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“…Many LMICs are now promoting and adopting nationwide breast cancer screening programs [3,10], and, due to key patent expirations [11,12], affordable breast cancer diagnostics, such as handheld ultrasound and low-cost mammography, are now emerging [13][14][15]. However, despite advances in early detection, few affordable treatments are available to address the breast cancer burden in LMICs.…”

Section: Introductionmentioning

confidence: 99%

Thermal Characterization and Preclinical Feasibility Verification of an Accessible, Carbon Dioxide-Based Cryotherapy System

Hu,

Gordon,

Ogg

et al. 2024

Bioengineering

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To investigate the potential of an affordable cryotherapy device for the accessible treatment of breast cancer, the performance of a novel carbon dioxide-based device was evaluated through both benchtop testing and an in vivo canine model. This novel device was quantitatively compared to a commercial device that utilizes argon gas as the cryogen. The thermal behavior of each device was characterized through calorimetry and by measuring the temperature profiles of iceballs generated in tissue phantoms. A 45 min treatment in a tissue phantom from the carbon dioxide device produced a 1.67 ± 0.06 cm diameter lethal isotherm that was equivalent to a 7 min treatment from the commercial argon-based device, which produced a 1.53 ± 0.15 cm diameter lethal isotherm. An in vivo treatment was performed with the carbon dioxide-based device in one spontaneously occurring canine mammary mass with two standard 10 min freezes. Following cryotherapy, this mass was surgically resected and analyzed for necrosis margins via histopathology. The histopathology margin of necrosis from the in vivo treatment with the carbon dioxide device at 14 days post-cryoablation was 1.57 cm. While carbon dioxide gas has historically been considered an impractical cryogen due to its low working pressure and high boiling point, this study shows that carbon dioxide-based cryotherapy may be equivalent to conventional argon-based cryotherapy in size of the ablation zone in a standard treatment time. The feasibility of the carbon dioxide device demonstrated in this study is an important step towards bringing accessible breast cancer treatment to women in low-resource settings.

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Section: Introductionmentioning

confidence: 99%

Thermal Characterization and Preclinical Feasibility Verification of an Accessible, Carbon Dioxide-Based Cryotherapy System

Hu,

Gordon,

Ogg

et al. 2024

Bioengineering

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Thermal Characterization and Preclinical Validation of an Accessible, Carbon Dioxide-Based Cryotherapy System

Hu,

Gordon,

Ogg

et al. 2024

Preprint

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To investigate the potential of an affordable cryotherapy device for accessible treatment of breast cancer, the performance of a novel carbon dioxide-based device was evaluated through both benchtop and in vivo canine models. This novel device was quantitatively compared to a commercial device that utilizes argon gas as the cryogen. The thermal behavior of each device was characterized through calorimetry and by measuring the temperature profiles of iceballs generated in tissue phantoms. A 45-minute treatment from the carbon dioxide device in a tissue phantom produced a 1.67 +/- 0.06 cm diameter lethal isotherm that was equivalent to a 7-minute treatment from the commercial argon-based device which produced a 1.53 +/- 0.15 cm diameter lethal isotherm. In vivo validation was performed with the carbon dioxide-based device in one spontaneously occurring canine mammary mass with two standard 10-minutes freezes. Following cryotherapy, this mass was surgically resected and analyzed for necrosis margins via histopathology. The histopathology margin of necrosis from the in vivo treatment with the carbon dioxide device at 14 days post cryoablation was 1.57 cm. While carbon dioxide gas has historically been considered an impractical cryogen due to its low working pressure and high boiling point, this study shows that carbon dioxide-based cryotherapy may be equivalent to conventional argon-based cryotherapy in the size of the ablation zone in a standard treatment time. The validation of the carbon dioxide device performed in this study is an important step towards bringing accessible breast cancer treatment to women in low-resource settings.

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The Clinical Utility of a Hand-Held Piezoelectric Scanner in the Detection of Early Tumor and Changes in Breast Texture

Gonçalves,

Nogueira,

Stock

et al. 2024

Cureus

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Background Breast cancer (BC) is one of the leading causes of cancer death in females worldwide. Screening with mammography (MMG) is limited in low- and middle-income countries (LMICs). The implementation of an affordable and effective screening method is crucial. The intelligent breast examination (iBE) has emerged as a portable device with a glove shape using piezoelectricity. This experimental study evaluates the effectiveness of the device by comparing it with mammography (MMG), breast magnetic resonance imaging (MRI), and clinical breast examination (CBE). Methods This study included patients admitted to the senology unit who were under surveillance in a medical oncology unit. iBE was performed after each CBE and compared with Breast Image Reporting and Data System (BI-RADS) classifications. MMG/MRI was classified as negative (BI-RADS ≤2) or positive (BI-RADS ≥3). Measures of accuracy and agreement between tests were calculated. Results A total of 103 females were included between September 2022 and September 2023, who underwent iBE, CBE, and MMG/MRI. CBE and MMG showed moderate agreement in categorization (ρ=0.99). With a specificity for predicting a negative MMG of 90.8% and a negative predictive value of 79.7%. Benign findings, cysts, fibroadenoma, and benign microcalcifications were presented in 80 patients (seromas and non-suspicious hypoechogenic images). The performance of iBE was evaluated by comparing the breast with alterations to the control breast within each BI-RADS categorization. Conclusion As of now, iBE does not identify breast changes. The improvement proposals emphasized the incorporation of accelerometer sensors, signal conditioning to allow for the collection of compression and decompression data from the sensors, and consideration of pressure stress. These improvements are crucial to optimize the iBE's ability to detect changes in breast texture, enhancing the iBE's effectiveness in the early detection of BC.

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Can the Clinical Utility of iBreastExam, a Novel Device, Aid in Optimizing Breast Cancer Diagnosis? A Systematic Review

Cited by 3 publications

References 36 publications

Thermal Characterization and Preclinical Feasibility Verification of an Accessible, Carbon Dioxide-Based Cryotherapy System

Thermal Characterization and Preclinical Feasibility Verification of an Accessible, Carbon Dioxide-Based Cryotherapy System

Thermal Characterization and Preclinical Validation of an Accessible, Carbon Dioxide-Based Cryotherapy System

The Clinical Utility of a Hand-Held Piezoelectric Scanner in the Detection of Early Tumor and Changes in Breast Texture

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