Diagnostic Ultrasound for Breast Cancer Screening

No longer recruiting at 1 trial location

Overseen By Debbie Bennett, M.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Breast implants, Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to distinguish between cancerous and non-cancerous breast lumps using a special handheld tool, the Hand-held Hybrid Probe. This tool combines ultrasound (imaging with sound waves) and near-infrared light to examine blood flow near the lump. Women with noticeable lumps on ultrasound, especially those advised to undergo a biopsy, might be suitable for this study. The goal is to enhance breast cancer diagnosis and monitoring, particularly before and during treatment. As an unphased trial, this study allows participants to contribute to innovative advancements in breast cancer diagnostics.

Do I have to stop taking my current medications for this trial?

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

What prior data suggests that this ultrasound-guided diffuse optical tomography is safe for breast cancer screening?

Research shows that the hand-held hybrid probe used in ultrasound-guided diffuse optical tomography (DOT) is generally safe for breast cancer screening. This method employs ultrasound and near-infrared light to examine breast tissue. Studies indicate that this technique is non-invasive, meaning it doesn't involve surgery, and it doesn't use radiation, enhancing its safety.

Initial findings suggest that patients tolerate this type of imaging well. Research reports no serious side effects from using the probe. Since this tool is used alongside standard ultrasound, its safety is comparable to what women experience during regular ultrasound exams.

In summary, current research supports the safety of this hand-held hybrid probe for breast cancer screening. The technology is designed to be safe and easy for patients, without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of a hand-held hybrid probe for breast cancer screening because it combines ultrasound (US) and near-infrared (NIR) imaging into one device. This integration allows for more detailed imaging of breast tissue compared to traditional ultrasound or mammography alone. The hybrid probe can potentially improve the accuracy of breast cancer detection by providing more comprehensive scans, which could lead to earlier and more precise diagnoses. By enhancing imaging techniques, this approach may reduce the need for invasive procedures like biopsies.

What evidence suggests that this hand-held hybrid probe is effective for breast cancer screening?

Research has shown that ultrasound-guided diffuse optical tomography (DOT), which participants in this trial will experience, effectively distinguishes between cancerous and non-cancerous breast lumps. This method uses ultrasound and near-infrared light to detect changes in blood flow and tissue, indicating cancer. Early results are promising in evaluating breast cancer patients' responses to chemotherapy. Studies have found that this technique provides clear images of breast tumors, aiding doctors in making better treatment decisions. Overall, ultrasound-guided DOT holds potential as a valuable tool for diagnosing breast cancer and monitoring treatment. ^{1 2 3 6 7}

Who Is on the Research Team?

Debbie Bennett, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older with visible breast abnormalities needing a biopsy. Participants must be able to consent and have specific types of lesions (BI-RADS 3, 4A, B, C, and 5). Excluded are pregnant women, those with certain previous treatments or conditions like implants or small lesions near the skin.

Inclusion Criteria

I am a woman over 18 with a breast abnormality needing a biopsy.

I chose a biopsy over imaging for my probably benign breast finding.

Willing and able to provide informed consent

Exclusion Criteria

You have breast implants.

Superficial abnormalities located entirely within (i.e. less than) 5mm of the overlying skin

I have had radiation on the breast opposite to the one currently affected.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training Set

20 patients will undergo US-DOT and CEM to train study readers and assess variability

Estimated 87 months for completion of enrollment

Prospective Trial

US-DOT imaging exam and standard of care breast biopsy or FNA performed

Estimated 87 months for completion of enrollment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hand-held hybrid probe

Trial Overview The study tests a hand-held probe combining ultrasound and optical sensors to differentiate between benign and malignant breast tissue without invasive biopsies. It aims to reduce unnecessary procedures by improving diagnostic accuracy through imaging tumor-related blood vessels.

How Is the Trial Designed?

Group I: US-DOT (US/NIR) Imaging Experimental Treatment 1 Intervention

* US-DOT (US/NIR) Imaging Exam * Breast biopsy or FNA performed (standard of care) * A hand-held hybrid probe will be used for the scans

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

The two-stage classification strategy using ultrasound (US) and diffuse optical tomography (DOT) achieved a high accuracy of 94.6% in distinguishing between benign and malignant breast lesions, significantly outperforming single-modality models.

In the first stage, the system successfully identified 73% of benign cases without needing image reconstruction, indicating its potential for fast and automated breast cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-stage classification strategy for breast cancer diagnosis using ultrasound-guided diffuse optical tomography and deep learning. Zhang, M., Li, S., Xue, M., et al.[2023]

In a study of 198 women with 214 breast lesions, ultrasound-guided diffused optical tomography (DOT) effectively differentiated malignant from benign lesions based on total hemoglobin concentration (THC), with malignant lesions showing significantly higher THC levels (222.2 micromol/L) compared to benign lesions (125.5 micromol/L).

Using a THC cutoff of 140 micromol/L, DOT demonstrated a sensitivity of 83.9% and specificity of 66.7%, indicating its potential as a noninvasive imaging technique for breast cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

US-guided diffused optical tomography: a promising functional imaging technique in breast lesions. You, SS., Jiang, YX., Zhu, QL., et al.[2021]

The study involved 102 women with 136 breast lesions and found that using diffuse optical tomography (DOT) combined with conventional ultrasound (US) significantly improves the accuracy of differentiating malignant from benign breast lesions, achieving 100% sensitivity and 96.3% overall accuracy.

The average total hemoglobin concentration was significantly higher in malignant lesions compared to benign ones, indicating that hemoglobin levels can be a useful biomarker in assessing breast lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Solid breast lesions: clinical experience with US-guided diffuse optical tomography combined with conventional US. Zhi, W., Gu, X., Qin, J., et al.[2012]

Ultrasound-guided diffuse optical tomography (US-guided DOT) shows promise in predicting and monitoring the outcomes of neoadjuvant chemotherapy (NAC) in breast cancer patients, indicating its potential as a valuable tool in treatment planning.

The review highlights advancements in optical tomography systems that make them portable and suitable for clinical use across multiple sites, enhancing accessibility for patient monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Diffuse Optical Tomography for Predicting and Monitoring Neoadjuvant Chemotherapy of Breast Cancers: Recent Progress. Xu, C., Vavadi, H., Merkulov, A., et al.[2018]

In a study of 61 women undergoing ultrasound-guided breast biopsy, the addition of ultrasound-guided diffuse optical tomography (US-guided DOT) significantly reduced the number of suspicious BI-RADS assessments for benign lesions by 23.5%, indicating improved diagnostic accuracy.

The study found that a hemoglobin threshold of 78.5 µM provided an 80% sensitivity and 89% specificity for detecting malignancy, suggesting that US-guided DOT can enhance the identification of cancerous lesions compared to conventional imaging alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective assessment of adjunctive ultrasound-guided diffuse optical tomography in women undergoing breast biopsy: Impact on BI-RADS assessments. Poplack, SP., Young, CA., Hagemann, IS., et al.[2022]

The combination of diffuse optical tomography and ultrasound significantly enhances the classification of breast lesions, achieving over 75% accuracy in identifying benign and malignant tumors based on simulated data.

Using a two-region reconstruction method alongside machine learning techniques, the accuracy of lesion classification can exceed 80%, demonstrating the potential for improved diagnostic capabilities in breast cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a pipeline for simulation, reconstruction, and classification in ultrasound-aided diffuse optical tomography of breast tumors. Di Sciacca, G., Maffeis, G., Farina, A., et al.[2022]

The newly developed ultrasound-guided diffuse optical tomography technique shows promise in improving breast cancer diagnosis and predicting chemotherapy response, based on data from 297 female patients.

By accounting for the chest wall's impact on optical properties, the technique significantly enhanced the accuracy of distinguishing between malignant and benign lesions, with area-under-the-curve (AUC) improvements indicating better diagnostic performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving breast cancer diagnosis by reducing chest wall effect in diffuse optical tomography. Zhou, F., Mostafa, A., Zhu, Q.[2019]

In a study of 88 breast cancer patients, ultrasound-guided diffuse optical tomography (US-guided DOT) effectively predicted the response to neoadjuvant chemotherapy (NAC) by measuring changes in total hemoglobin concentration (ΔTHC) and lesion size (ΔSIZE).

The established cutoff values for predicting treatment response were ΔTHC of 23.9% and ΔSIZE of 42.6%, with significant predictive accuracy observed after three rounds of chemotherapy, particularly for ΔSIZE, indicating its potential utility in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting Treatment Response of Breast Cancer to Neoadjuvant Chemotherapy Using Ultrasound-Guided Diffuse Optical Tomography. Zhi, W., Liu, G., Chang, C., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10659805/

Automated pipeline for breast cancer diagnosis using US ... In this study, we aim at providing an automated US-assisted DOT pre-processing, imaging and diagnosis pipeline to achieve near real-time diagnosis.

2. opg.optica.org opg.optica.org/abstract.cfm?uri=boe-16-4-1582

Towards real-time diffuse optical tomography with a ... The model is demonstrated with both a simulated dataset, and experimental FD-DOT data collected with a fiber-based mechanical probe and a tumor-emulating ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6197842/

Compact ultrasound-guided diffuse optical tomography ... We have reported initial results of using US-guided DOT for breast cancer diagnosis and for neoadjuvant chemotherapy assessment using our first and second ...

4. withpower.com withpower.com/trial/phase-11-2018-616f9

Diagnostic Ultrasound for Breast Cancer Screening Ultrasound-guided diffuse optical tomography (DOT) has demonstrated its potential role in differentiating malignant and benign breast abnormalities and in ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1055320707000257

Optical Tomography with Ultrasound Localization for ... Optical tomography with ultrasound (US) localization uses coregistered ultrasound images to guide optical imaging reconstruction.

6. researchgate.net researchgate.net/publication/282834717_Development_of_a_Handheld_Diffuse_Optical_Breast_Cancer_Assessment_Probe

(PDF) Development of a handheld diffuse optical breast ... PDF | Diffuse Optical Spectroscopy (DOS) is a promising non-invasive and non-ionizing technique for breast anomaly detection.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0143816624000551

Optical characterization of the first hand-held probe for ... It proposes the integration of time-resolved multi-wavelength Diffuse Optical Tomography (DOT) and ultrasound-based imaging techniques (B-mode ultrasounds—US, ...