Diagnostic Ultrasound for Breast Cancer Screening

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

293 Participants Needed

Trial Summary

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 data supports the idea that Diagnostic Ultrasound for Breast Cancer Screening is an effective treatment?

The available research shows that Diagnostic Ultrasound for Breast Cancer Screening, also known as ultrasound-guided diffuse optical tomography (US-guided DOT), is effective in identifying breast cancer. It helps doctors tell the difference between cancerous and non-cancerous breast lumps. One study found that using this method can accurately predict how well breast cancer will respond to chemotherapy, which is a common cancer treatment. Another study showed that combining this technique with regular ultrasound improves the accuracy of breast cancer diagnosis. Overall, these studies suggest that this treatment is a promising tool for better diagnosing and managing breast cancer. ^{1 2 3 4 5}

What safety data is available for ultrasound-guided diffuse optical tomography in breast cancer screening?

The provided research abstracts focus on the feasibility, clinical efficacy, and diagnostic potential of ultrasound-guided diffuse optical tomography (US-guided DOT) in breast cancer screening and treatment monitoring. However, they do not explicitly mention safety data. The studies highlight the technique's ability to differentiate between malignant and benign breast lesions, its impact on BI-RADS assessments, and its use in monitoring chemotherapy outcomes. While these aspects suggest clinical utility, specific safety data would need to be obtained from detailed study results or additional safety-focused research. ^{1 2 4 5 6}

Is the treatment in the trial 'Diagnostic Ultrasound for Breast Cancer Screening' promising?

Yes, the treatment, which combines ultrasound with diffuse optical tomography, is promising for breast cancer screening. It helps doctors accurately tell the difference between cancerous and non-cancerous breast lumps, making diagnosis faster and more reliable. ^{1 2 5 7 8}

What is the purpose of this trial?

Ultrasound-guided diffuse optical tomography (DOT) has demonstrated its potential role in differentiating malignant and benign breast abnormalities and in predicting and monitoring the neoadjuvant chemotherapy (NAC) response of breast cancer. This unique approach employs a commercial ultrasound (US) transducer and near infrared (NIR) optical imaging sensors mounted on a hand-held US probe. The co-registered US is used for lesion localization, and optical sensors are used for imaging tumor related vascularity.

Research Team

Debbie Bennett, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Phase I - Training Set Experimental Treatment 1 Intervention

* 20 patients will be recruited to undergo US-DOT and CEM to allow for training study readers in assessing US-DOT data, intra-observer variability and to assess inter-observer variability in the assessment of US-DOT data * A hand-held hybrid probe will be used for the scans

Group II: Phase 2: Prospective Trial 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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

US-guided diffused optical tomography: a promising functional imaging technique in breast lesions. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Solid breast lesions: clinical experience with US-guided diffuse optical tomography combined with conventional US. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

Predicting Treatment Response of Breast Cancer to Neoadjuvant Chemotherapy Using Ultrasound-Guided Diffuse Optical Tomography. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Prospective assessment of adjunctive ultrasound-guided diffuse optical tomography in women undergoing breast biopsy: Impact on BI-RADS assessments. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Two-stage classification strategy for breast cancer diagnosis using ultrasound-guided diffuse optical tomography and deep learning. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Diffuse Optical Tomography for Predicting and Monitoring Neoadjuvant Chemotherapy of Breast Cancers: Recent Progress. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a pipeline for simulation, reconstruction, and classification in ultrasound-aided diffuse optical tomography of breast tumors. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Improving breast cancer diagnosis by reducing chest wall effect in diffuse optical tomography. [2019]