What is the mechanism of action of this treatment?

Common treatments for breast cancer include surgery, chemotherapy, radiation therapy, and targeted therapies. Surgery involves the physical removal of the tumor, which is essential for localized cancer. Chemotherapy uses drugs to kill rapidly dividing cancer cells, which can be effective for both localized and metastatic cancer. Radiation therapy uses high-energy rays to destroy cancer cells, often used post-surgery to eliminate residual cells. Targeted therapies, such as hormone therapy and HER2 inhibitors, block specific molecules involved in cancer growth. Techniques like Restriction Spectrum Imaging (RSI) enhance imaging by focusing on the restricted diffusion of water molecules in tissues, potentially improving the detection and characterization of cancerous tissues. This matters for breast cancer patients as accurate imaging and effective treatments are crucial for improving outcomes and survival rates.

What side effects are associated with this type of intervention?

Common treatments for breast cancer include surgery, chemotherapy, radiotherapy, and advanced imaging techniques like MRI. Surgery can lead to pain, infection, and lymphedema. Chemotherapy often causes nausea, fatigue, hair loss, and increased infection risk. Radiotherapy may result in skin irritation, fatigue, and long-term risks like secondary cancers. Advanced imaging techniques, such as MRI, are generally safe but can cause discomfort and anxiety during the procedure. These treatments aim to effectively manage breast cancer but come with potential side effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved various advanced imaging techniques and related drugs for the treatment of breast cancer. While specific approvals for Restriction Spectrum Imaging (RSI) are not detailed, MRI has been widely used and studied for breast cancer screening and monitoring. MRI techniques, including those that assess cancer enhancement patterns and tumor distribution, have been instrumental in improving the specificity of cancer detection and monitoring response to therapy. These imaging advancements complement the use of systemic therapies and targeted treatments, enhancing the overall management of breast cancer.

What other types of research exist?

Promising novel alternatives to Restriction Spectrum Imaging (RSI) for breast cancer patients include: <ol> <li>Diffusion-Weighted Imaging (DWI) - Uses the diffusion of water molecules to generate contrast in MRI images, improving the identification of malignant tissues.</li> <li></li> </ol> Magnetic Resonance Spectroscopic Imaging (MRSI) - Provides metabolic information about breast lesions, potentially enhancing cancer detection and characterization. 3. Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) - Combines metabolic and anatomical imaging, offering detailed insights into breast cancer. 4. Dynamic Contrast-Enhanced MRI (DCE-MRI) - Uses contrast agents to highlight blood flow and vascular properties of breast tissues, aiding in the differentiation of benign and malignant lesions.

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Imaging

RSI vs MRI for Breast Cancer Screening

N/A

Waitlist Available

Led By Vandana Dialani, MD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new imaging technique called RSI to see if it can better detect breast cancer compared to the standard MRI. RSI looks at how water moves in tissues to find tumors more clearly.

Who is the study for?

This trial is for women aged 18 or older who are asymptomatic for breast disease and due for routine screening with MRI or mammogram/ultrasound. Radiologists participating must have experience in interpreting breast MRIs. Women with breast implants, claustrophobia, renal insufficiency, unsafe devices for MRI, planned biopsies before the study, pregnancy/nursing status, or history of reaction to gadolinium contrast cannot participate.

What is being tested?

The study compares Restriction Spectrum Imaging (RSI), a potential new technique for breast cancer screening, against the conventional Breast Magnetic Resonance Imaging (MRI) that healthcare professionals currently use.

What are the potential side effects?

Since RSI is an imaging technique similar to MRI without using intravenous contrast agents like gadolinium used in standard MRIs, it may reduce the risk of side effects related to these agents such as allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diagnostic accuracy of breast restriction spectrum imaging (RSI) in comparison to conventional breast MRI

Secondary study objectives

Diagnostic accuracy of RSI compared to that of abbreviated MRI (Ab-MRI) in breast cancer screening

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SCREENING MG BI-RADS 4/5Experimental Treatment1 Intervention

* RSI is a DWI sequence with a built in distortion-correction technique that can be applied to any diffusion technique using echo planar imaging acquisition. * RSI will be performed using pulsed-field gradient, spin-echo, echo planar imaging with "multi-shell" diffusion data . * The b0 images will be collected in both the forward and reverse phase encoding directions to allow for post-processing correction of spatial distortion from magnetic field.

Group II: SCREENING MRIActive Control1 Intervention

Standard MRI procedure will be used.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RSI

2008

Completed Phase 4

~240

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include surgery, chemotherapy, radiation therapy, and targeted therapies. Surgery involves the physical removal of the tumor, which is essential for localized cancer. Chemotherapy uses drugs to kill rapidly dividing cancer cells, which can be effective for both localized and metastatic cancer. Radiation therapy uses high-energy rays to destroy cancer cells, often used post-surgery to eliminate residual cells. Targeted therapies, such as hormone therapy and HER2 inhibitors, block specific molecules involved in cancer growth. Techniques like Restriction Spectrum Imaging (RSI) enhance imaging by focusing on the restricted diffusion of water molecules in tissues, potentially improving the detection and characterization of cancerous tissues. This matters for breast cancer patients as accurate imaging and effective treatments are crucial for improving outcomes and survival rates.

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