MRI-Guided Radiation for Early Breast Cancer

(MAPBI Trial)

Overseen By Cancer Connect

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Wisconsin, Madison

Must not be taking: Hormonal agents

Disqualifiers: Men, BRCA1/2 mutation, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 week

30 Participants Needed

Trial Summary

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

The trial protocol does not specify if you need to stop taking your current medications, but it does exclude participants who are on hormonal agents like tamoxifen or aromatase inhibitors. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment MRI-Guided Radiation for Early Breast Cancer?

Research shows that MRI-guided radiotherapy can improve the accuracy of targeting the tumor while sparing healthy tissue, which is beneficial for treatments like Accelerated Partial Breast Irradiation (APBI). This approach has been successfully used in other cancers, such as hepatobiliary cancers, by providing excellent soft tissue definition and real-time monitoring, which may enhance treatment outcomes. ^{1 2 3 4 5}

Is MRI-guided radiation therapy safe for humans?

MRI-guided radiation therapy, including treatments like accelerated partial breast irradiation (APBI), has been studied for safety. Research shows that while the skin dose can increase with whole-breast irradiation due to the magnetic field, this effect is negligible in partial-breast treatments, suggesting it is generally safe for humans. ^{2 5 6 7 8}

How is MRI-Guided Radiation for Early Breast Cancer different from other treatments?

MRI-Guided Radiation for Early Breast Cancer is unique because it uses magnetic resonance imaging (MRI) to guide radiation therapy, allowing for more precise targeting of the tumor and minimizing radiation exposure to surrounding healthy tissue. This approach can reduce the risk of side effects and improve treatment accuracy compared to traditional radiation methods. ^{2 3 4 5 8}

What is the purpose of this trial?

This trial will investigate a novel 3-fraction radiation regimen for participants undergoing breast-conserving therapy (BCT) for early breast cancer that will: 1) significantly reduce the duration of treatment and can be completed in one-week (5 working days) and 2) MRI-guided radiotherapy (MRIdian) would limit the volume of normal tissue radiated and therefore resultant toxicity. The hypothesis is that 3-fraction radiation therapy can be delivered safely without compromising the therapeutic ratio. Participants can expect to be on study for follow up up to 5 years.

Research Team

Bethany Anderson, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for individuals with early-stage breast cancer who have undergone a lumpectomy. Participants must be able to undergo MRI scans, which are used in planning and delivering the treatment, and their lumpectomy cavity should be visible on CT and MRI. Women of childbearing potential must test negative for pregnancy. Those with a history of non-breast cancers can join if they've been disease-free for 5+ years or had certain skin or localized cancers within that time.

Inclusion Criteria

The area where my lump was removed is clearly seen on scans.

Pregnancy test negative in women of child bearing potential (WOCBP).

I can safely have an MRI scan.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a novel 3-fraction radiation regimen over 5-6 days, with treatments on alternative weekdays and a minimum interval of 40 hours between fractions

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including quality of life and cosmesis up to 5 years

5 years

Regular visits (in-person and virtual) at specified intervals

Treatment Details

Interventions

• MRIdian Radiation Treatment Unit

Trial Overview The study is testing an innovative radiation therapy delivered in just three sessions over one week using the MRIdian system, which combines MRI imaging with radiation therapy to target tumors more precisely while sparing healthy tissue. The goal is to see if this quick treatment can effectively control cancer without causing significant side effects.

Participant Groups

Group I: 8.2 Gy Radiation Therapy Experimental Treatment 1 Intervention

Accelerated partial breast irradiation using 3 x 8.2 Gy to the lumpectomy cavity with a 3mm PTV margin. Treatment duration will be 5-6 days and treatments will be on alternative weekdays, with a minimum interval of 40 hours between subsequent fractions.

MRIdian Radiation Treatment Unit is already approved in United States, European Union, Canada for the following indications:

Approved in United States as MRIdian Radiation Treatment Unit for:

• Early-stage invasive breast cancer
• Ductal carcinoma in situ (DCIS)

Approved in European Union as MRIdian Radiation Treatment Unit for:

• Early-stage invasive breast cancer
• Ductal carcinoma in situ (DCIS)

Approved in Canada as MRIdian Radiation Treatment Unit for:

• Early-stage invasive breast cancer
• Ductal carcinoma in situ (DCIS)

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Findings from Research

The MRIdian® MR linear accelerator in the UK has successfully implemented Stereotactic MRI-guided Adaptive Radiotherapy (SMART) for treating hepatobiliary cancers, allowing for precise targeting and real-time adjustments during treatment for 50 patients in just five months.

SMART offers significant advantages such as excellent soft tissue visualization, daily recontouring of targets, and automatic respiratory-gated treatment delivery, making it suitable for complex tumors that may not be treatable with traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Stereotactic MRI-Guided Adaptive Radiotherapy (SMART) for Hepatobiliary and Pancreatic Cancers in the United Kingdom - Fifty in Five. Gaya, A., Camilleri, P., Nash, A., et al.[2021]

Accelerated partial breast irradiation (APBI) using an MR-Linac is feasible in both prone and supine positions, with all treatment plans meeting target coverage and organ-at-risk (OAR) constraints for 20 patients studied.

The prone position resulted in significantly lower radiation exposure to the ipsilateral lung and shorter estimated delivery times, although most patients preferred the supine position for comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prone vs. supine accelerated partial breast irradiation on an MR-Linac: A planning study. Groot Koerkamp, ML., van der Leij, F., van 't Westeinde, T., et al.[2021]

Neoadjuvant partial breast irradiation (PBI) is being researched to minimize the amount of breast tissue exposed to radiation, which could lower the risk of long-term side effects from treatment.

Magnetic resonance (MR)-guided radiotherapy, particularly using MR-linac systems, may enhance tumor visibility during treatment, potentially allowing for even more precise targeting and reduced radiation exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing MR-Guided Radiotherapy for Breast Cancer Patients. Groot Koerkamp, ML., Vasmel, JE., Russell, NS., et al.[2021]

Breast MRI detected synchronous mammographically occult lesions in 5.8% of early-stage breast cancer patients, highlighting its potential to identify additional cancers that might affect treatment decisions for accelerated partial breast irradiation (APBI).

The study found that certain factors, such as lobular histology and higher cancer stages, were significantly associated with the presence of additional ipsilateral disease, suggesting that MRI could be particularly beneficial for specific patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative breast magnetic resonance imaging in early breast cancer: implications for partial breast irradiation. Tendulkar, RD., Chellman-Jeffers, M., Rybicki, LA., et al.[2009]

In a study involving 30 women with early-stage breast cancer, the use of MR-guided radiation therapy for accelerated partial-breast irradiation showed minimal intrafractional motion of the surgical cavity, with an average displacement of only 0.6 mm.

The difference between the planned and delivered radiation dose was very small, at just 0.6%, indicating that this method effectively delivers the intended treatment with high precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Image Guided Radiation Therapy for External Beam Accelerated Partial-Breast Irradiation: Evaluation of Delivered Dose and Intrafractional Cavity Motion. Acharya, S., Fischer-Valuck, BW., Mazur, TR., et al.[2022]

In a study involving 10 early-stage breast cancer patients, the use of an MRI/linac system during whole-breast irradiation (WBI) increased the skin dose due to the electron return effect, which could be a concern for treatment safety.

Conversely, during accelerated partial-breast irradiation (APBI), the magnetic field had negligible effects on skin dose, suggesting that MR-guided partial-breast treatments could be a promising option for improving radiotherapy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR-guided breast radiotherapy: feasibility and magnetic-field impact on skin dose. van Heijst, TC., den Hartogh, MD., Lagendijk, JJ., et al.[2022]

Magnetic resonance-guided radiation therapy (MRgRT) is increasingly utilized in the US, with a 59.6% annual growth rate in treatment courses from 2014 to 2020, particularly for ultra-hypofractionated regimens, which accounted for 70.3% of all courses.

The technology has shown a significant shift towards adaptive radiation therapy, with 38.5% of treatment courses involving adaptive fractions, especially in ultra-hypofractionated schedules, indicating a major advancement in the precision and personalization of cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of utilization and clinical adoption of 0.35 Tesla MR-guided radiation therapy in the United States - Understanding the transition to adaptive, ultra-hypofractionated treatments. Chuong, MD., Clark, MA., Henke, LE., et al.[2022]

In a study of 180 women evaluated for accelerated partial breast irradiation (APBI), breast MRI identified additional cancerous lesions in 12% of candidates, highlighting its importance in detecting multifocal or multicentric disease before treatment.

Premenopausal women and those with tumors larger than 2 cm were more likely to have MRI-detected multifocal or multicentric disease, suggesting that these factors may influence the effectiveness of MRI in identifying the extent of breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining an optimal role for breast magnetic resonance imaging when evaluating patients otherwise eligible for accelerated partial breast irradiation. Horst, KC., Fero, KE., Ikeda, DM., et al.[2019]

References

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

Implementation of Stereotactic MRI-Guided Adaptive Radiotherapy (SMART) for Hepatobiliary and Pancreatic Cancers in the United Kingdom - Fifty in Five. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Prone vs. supine accelerated partial breast irradiation on an MR-Linac: A planning study. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Optimizing MR-Guided Radiotherapy for Breast Cancer Patients. [2021]

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

Preoperative breast magnetic resonance imaging in early breast cancer: implications for partial breast irradiation. [2009]

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

Magnetic Resonance Image Guided Radiation Therapy for External Beam Accelerated Partial-Breast Irradiation: Evaluation of Delivered Dose and Intrafractional Cavity Motion. [2022]

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

MR-guided breast radiotherapy: feasibility and magnetic-field impact on skin dose. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Patterns of utilization and clinical adoption of 0.35 Tesla MR-guided radiation therapy in the United States - Understanding the transition to adaptive, ultra-hypofractionated treatments. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Defining an optimal role for breast magnetic resonance imaging when evaluating patients otherwise eligible for accelerated partial breast irradiation. [2019]