MRg-NIRS Imaging for Breast Cancer

(MRg-NIRS Trial)

Overseen By Shudong Jiang, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Keith D. Paulsen

Disqualifiers: Pacemaker, Metal implant, Claustrophobia, Renal failure, others

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

Compensation: Varies

Number of Visits: 1

20 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment MRg-NIRS Imaging System for breast cancer?

Research shows that MRg-NIRS Imaging can effectively differentiate between malignant (cancerous) and benign (non-cancerous) breast lesions by measuring blood and oxygen levels in the tissue. This technique provides detailed images that help in identifying cancerous tissues, potentially improving diagnosis and reducing unnecessary biopsies. ^{1 2 3 4 5}

Is MRg-NIRS Imaging safe for humans?

The research does not provide specific safety data for MRg-NIRS Imaging, but it has been used in studies with healthy volunteers and patients, suggesting it is generally considered safe for human use. ^{2 5 6 7 8}

How does the MRg-NIRS treatment for breast cancer differ from other treatments?

The MRg-NIRS treatment combines magnetic resonance imaging (MRI) with near-infrared spectroscopy (NIRS) to provide detailed images and functional information about breast tumors, such as blood and water content, which can improve diagnostic accuracy and reduce unnecessary biopsies. This approach is unique because it integrates molecular spectroscopy with MRI, offering a noninvasive way to assess the tumor's characteristics and potentially guide treatment decisions. ^{2 3 4 9 10}

What is the purpose of this trial?

This trial is a study of 20 women with breast cancer to evaluate the addition of MR-guided (MRg) near-infrared spectroscopy (NIRS) with and without contrast, as part of a program to improve clinical management of women receiving breast magnetic resonance imaging (MRI).

Research Team

Keith D. Paulsen, PhD

Principal Investigator

Dartmouth College

Eligibility Criteria

This trial is for women diagnosed with breast cancer. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria and be able to undergo MRI procedures.

Inclusion Criteria

I am a woman aged 18 or older.

Participants capable of providing written informed consent

I have been recently diagnosed with breast cancer.

Exclusion Criteria

Pregnant women

Breast implants

Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Data Collection

Participants undergo MRg-NIRS imaging with and without contrast, and MRI-derived ROI data is collected

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• MRg-NIRS

Trial Overview The study is testing the use of a new imaging system called MRg-NIRS in women with breast cancer. It aims to see if this system can improve the management of their condition when added to standard MRI scans, with or without contrast.

Participant Groups

Group I: MR-guided NIRS Experimental Treatment 1 Intervention

The MRg-NIRS device will be tested to see if it accommodates different breast sizes, covers the breast fully, includes the axilla, is compatible with commercial breast MRI coil and/or biopsy systems, and the signal-to-noise ratio is high enough for MRg-NIRS image reconstruction. The study team will collect MRI-derived ROI data with T1, T2 and DCE-MRI sequences from 20 women with breast abnormalities and NIRS data concurrently. The study team will also collect diffuse optical signals at 48x48 detector source positions over one side of breast at 6 wavelengths.

Who Is Running the Clinical Trial?

Keith D. Paulsen

Lead Sponsor

Trials

1

Recruited

20+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

Findings from Research

The study analyzed data from 44 patients using breast MRI-guided near infrared spectroscopy (NIRS) to effectively differentiate between benign and malignant tumors, achieving significant results with total hemoglobin and tissue optical index measurements.

Optimizing the spatial sensitivity and incorporating spectral constraints were crucial for improving diagnostic accuracy, highlighting the need for optical systems that can uniformly cover the breast while accommodating various sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensitivity of MRI-guided near-infrared spectroscopy clinical breast exam data and its impact on diagnostic performance. Mastanduno, MA., Xu, J., El-Ghussein, F., et al.[2020]

A new near-infrared spectroscopy (NIRS) interface was developed to work alongside dynamic contrast-enhanced MRI (DCE-MRI), allowing for better imaging of breast tissues across various sizes and lesion locations, which enhances diagnostic capabilities.

This combined approach provides detailed information on hemoglobin content, oxygen saturation, and tissue composition, potentially increasing the specificity of breast cancer diagnoses and reducing unnecessary biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptable near-infrared spectroscopy fiber array for improved coupling to different breast sizes during clinical MRI. Mastanduno, MA., El-Ghussein, F., Jiang, S., et al.[2021]

A novel hybrid imaging system combining MRI and near-infrared (NIR) measurements was successfully tested on 14 patients, allowing for noninvasive characterization of breast cancer by quantifying hemoglobin levels and oxygen saturation in malignant versus benign lesions.

Breast cancers showed lower oxygen saturation and higher hemoglobin concentration compared to benign lesions, indicating that this technique could enhance diagnostic accuracy and treatment prognosis in breast cancer assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided diffuse optical spectroscopy of malignant and benign breast lesions. Ntziachristos, V., Yodh, AG., Schnall, MD., et al.[2019]

This pilot study utilized a novel multimodality instrument combining optical spectroscopy with MRI to analyze cancerous breast tissue, revealing important characteristics such as high hemoglobin and water levels, low oxygen saturation, and increased subcellular granularity.

The integration of spectroscopy with MRI allows for high-resolution imaging and detailed mapping of tissue properties, suggesting a promising approach for enhancing cancer diagnosis and treatment monitoring in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided optical spectroscopy provides molecular-specific information in vivo: MRI-guided spectroscopy of breast cancer hemoglobin, water, and scatterer size. Carpenter, CM., Pogue, BW., Jiang, S., et al.[2019]

The study investigated how different measurement parameters, such as view angle and wavelength, affect the sensitivity and edge resolution of detecting tumors in breast tissue using MR-derived maps under near-infrared (NIR) illumination.

By exploring a wide range of conditions, the research highlights the importance of optimizing data collection methods for imaging studies to improve tumor detection accuracy in breast cancer diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling of sensitivity and resolution to an included object in homogeneous scattering media and in MRI-derived breast maps. Pei, Y., Lin, FB., Barbour, R.[2019]

The study presents a new methodology that enhances the accuracy of hemoglobin quantification in breast imaging by reducing errors by up to 38%, which is crucial for distinguishing between malignant and benign lesions.

By integrating Dixon MR imaging to estimate water and fat content, the technique not only improves optical quantification but also increases the contrast between diseased and normal tissue, potentially allowing for fewer wavelengths to be used while maintaining accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR water quantitative priors improves the accuracy of optical breast imaging. Carpenter, CM., Pogue, BW., Jiang, S., et al.[2021]

Imaging oxygen saturation using near-infrared (NIR) tomography, especially when combined with MRI, can effectively differentiate between various types of breast tissue density, as shown in a study with 60 healthy volunteers.

In case studies of infiltrating ductal carcinomas, lower oxygen saturation was observed at tumor sites compared to surrounding healthy tissue, supporting the idea that larger tumors often experience hypoxia, which could aid in cancer diagnosis and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developments in quantitative oxygen-saturation imaging of breast tissue in vivo using multispectral near-infrared tomography. Srinivasan, S., Pogue, BW., Carpenter, C., et al.[2016]

Diffusion-weighted imaging (DWI)-guided magnetic resonance spectroscopy (MRS) using readout-segmented echo-planar imaging (RS-EPI) is effective in characterizing breast lesions, with a study of 258 patients showing significant differences in choline levels between malignant and benign lesions.

The technique demonstrated high accuracy, with ROC curve areas of 0.93 and 0.90 for choline signal-to-noise ratio and concentration, respectively, indicating its potential as a reliable diagnostic tool for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diffusion-Weighted Imaging-guided MR Spectroscopy in Breast Lesions using Readout-Segmented Echo-Planar Imaging. Sun, K., Chai, W., Fu, C., et al.[2020]

The combination of Magnetic Resonance (MR) and Near Infrared Spectroscopy (NIRS) offers a promising method to assess breast tumors by quantifying hemodynamics, water content, and cellular characteristics with high resolution.

The study demonstrates a novel 3D visualization technique that enhances the integration of optical data with MR images, potentially improving the clinical assessment of breast tissue during treatments like chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methodology development for three-dimensional MR-guided near infrared spectroscopy of breast tumors. Carpenter, CM., Srinivasan, S., Pogue, BW., et al.[2018]

MRI-guided near-infrared spectral tomography (NIRST) can effectively quantify hemoglobin concentration in breast tissue using only continuous wave (CW) measurements, which simplifies the diagnostic process.

The study, involving simulations and 24 patient cases, found that using only CW data to differentiate between malignant and benign breast lesions provides diagnostic performance comparable to more complex methods that include frequency domain data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance assessment of MRI guided continuous wave near-infrared spectral tomography for breast imaging. Feng, J., Jiang, S., Pogue, BW., et al.[2022]

References

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

Sensitivity of MRI-guided near-infrared spectroscopy clinical breast exam data and its impact on diagnostic performance. [2020]

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

Adaptable near-infrared spectroscopy fiber array for improved coupling to different breast sizes during clinical MRI. [2021]

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

MRI-guided diffuse optical spectroscopy of malignant and benign breast lesions. [2019]

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

Image-guided optical spectroscopy provides molecular-specific information in vivo: MRI-guided spectroscopy of breast cancer hemoglobin, water, and scatterer size. [2019]

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

Modeling of sensitivity and resolution to an included object in homogeneous scattering media and in MRI-derived breast maps. [2019]

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

MR water quantitative priors improves the accuracy of optical breast imaging. [2021]

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

Developments in quantitative oxygen-saturation imaging of breast tissue in vivo using multispectral near-infrared tomography. [2016]

8. Germany pubmed.ncbi.nlm.nih.gov

Diffusion-Weighted Imaging-guided MR Spectroscopy in Breast Lesions using Readout-Segmented Echo-Planar Imaging. [2020]

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

Methodology development for three-dimensional MR-guided near infrared spectroscopy of breast tumors. [2018]

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

Performance assessment of MRI guided continuous wave near-infrared spectral tomography for breast imaging. [2022]