MRI-Guided Radiation Therapy for Breast Cancer
(PPI Trial)
Recruiting in Palo Alto (17 mi)
Overseen byJohn Ng, M.D.
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Weill Medical College of Cornell University
No Placebo Group
Trial Summary
What is the purpose of this trial?The Investigators are investigating the potential role of MRI-guided Radiation Therapy for patients receiving breast radiotherapy in the prone position with a MRI-Linac radiotherapy system, the Precision Prone Irradiation (PPI) technique.
Hypothesis: The investigators would like to hypothesize that breast radiation therapy using MRI-guided system including the MRI-Linac (Arm 2) is comparable to the current standard of treatment using conventional CT-based system (Arm 1), in terms of local control of the disease at 2 year time point.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.
What data supports the idea that MRI-Guided Radiation Therapy for Breast Cancer is an effective treatment?
The available research shows that MRI-Guided Radiation Therapy for Breast Cancer can be effective because it helps to reduce the amount of healthy tissue exposed to radiation. This is important because it can lower the risk of side effects. For example, one study found that using MRI guidance in a prone position (lying face down) can reduce the radiation dose to the heart and lungs, which is beneficial for patients with left-sided breast cancer. Another study highlights that MRI guidance can improve the visibility of the tumor, allowing for more precise targeting and potentially better outcomes. Compared to traditional methods, MRI guidance can also reduce the number of treatment sessions needed, which can be more convenient for patients.
12345What safety data is available for MRI-guided radiation therapy for breast cancer?
The safety data for MRI-guided radiation therapy for breast cancer includes studies on the risk of radiation-induced secondary malignancies with partial breast irradiation using a 1.5 T MR-linac, which highlights potential long-term toxicities. Additionally, prone positioning for whole breast irradiation has been shown to result in lower toxicity and reduced lung and heart doses compared to supine positioning. MRI-guided stereotactic accelerated partial breast irradiation (MRgS-APBI) offers reduced irradiated volumes and radiation exposure while maintaining clinical outcomes, suggesting a favorable safety profile.
15678Is MRI-guided Precision Prone Irradiation a promising treatment for breast cancer?
Yes, MRI-guided Precision Prone Irradiation is promising because it can focus radiation more precisely on the tumor, reducing the amount of healthy breast tissue exposed to radiation. This precision helps lower the risk of side effects and improves the effectiveness of the treatment.
1291011Eligibility Criteria
This trial is for women over 50 with early-stage breast cancer (DCIS or Stage I) who've had a lumpectomy with clear margins. It's not for those who've had radiation on the same breast before, can't have an MRI, are more than 90 days post-surgery without chemo, or more than 60 days post-chemo.Inclusion Criteria
I am over 50, had surgery for early breast cancer or DCIS, with a small tumor removed cleanly.
My breast cancer was removed with clear margins.
My cancer has not spread to nearby lymph nodes.
+3 more
Exclusion Criteria
It has been over 60 days since my last chemotherapy session.
I cannot undergo MRI or am not suitable for MRI-based treatments.
My cancer has spread to other parts of my body.
+2 more
Participant Groups
The study compares two types of radiation therapy after breast-conserving surgery: standard CT-guided treatment and a new MRI-guided method called Precision Prone Irradiation (PPI), to see if they're equally effective at controlling cancer after two years.
2Treatment groups
Active Control
Group I: ARM 1 - CT-based breast radiation treatmentActive Control1 Intervention
Patients randomized to ARM 1 will receive 3000 cGy in 5 fractions partial breast radiotherapy with CT-based breast radiation treatment.
Group II: ARM 2 - MRI-based breast radiation treatmentActive Control1 Intervention
Patients randomized to ARM 2 will receive 3000 cGy in 5 fractions partial breast radiotherapy with MRI-based breast radiation treatment.
CT-guided Breast Irradiation is already approved in European Union, United States, Canada, Japan, Australia for the following indications:
🇪🇺 Approved in European Union as CT-guided Breast Irradiation for:
- Breast cancer
- Early-stage breast cancer
- Locally advanced breast cancer
🇺🇸 Approved in United States as CT-guided Breast Irradiation for:
- Breast cancer
- Early-stage breast cancer
- Locally advanced breast cancer
- Ductal carcinoma in situ (DCIS)
🇨🇦 Approved in Canada as CT-guided Breast Irradiation for:
- Breast cancer
- Early-stage breast cancer
- Locally advanced breast cancer
🇯🇵 Approved in Japan as CT-guided Breast Irradiation for:
- Breast cancer
- Early-stage breast cancer
🇦🇺 Approved in Australia as CT-guided Breast Irradiation for:
- Breast cancer
- Early-stage breast cancer
- Locally advanced breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Weill Cornell MedicineNew York, NY
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Who Is Running the Clinical Trial?
Weill Medical College of Cornell UniversityLead Sponsor
References
A comparative study based on deformable image registration of the target volumes for external-beam partial breast irradiation defined using preoperative prone magnetic resonance imaging and postoperative prone computed tomography imaging. [2020]To explore the differences and correlations between the target volumes defined using preoperative prone diagnostic magnetic resonance imaging (MRI) and postoperative prone computed tomography (CT) simulation imaging based on deformable image registration (DIR) for external-beam partial breast irradiation (EB-PBI) after breast-conserving surgery (BCS).
Optimizing MR-Guided Radiotherapy for Breast Cancer Patients. [2021]Current research in radiotherapy (RT) for breast cancer is evaluating neoadjuvant as opposed to adjuvant partial breast irradiation (PBI) with the aim of reducing the volume of breast tissue irradiated and therefore the risk of late treatment-related toxicity. The development of magnetic resonance (MR)-guided RT, including dedicated MR-guided RT systems [hybrid machines combining an MR scanner with a linear accelerator (MR-linac) or 60Co sources], could potentially reduce the irradiated volume even further by improving tumour visibility before and during each RT treatment. In this position paper, we discuss MR guidance in relation to each step of the breast RT planning and treatment pathway, focusing on the application of MR-guided RT to neoadjuvant PBI.
MRI in breast cancer radiotherapy in prone and supine positions. [2022]Contemporary radiotherapy (RT) planning utilizes both a computed tomography (CT) scan either in prone or supine position with no breast compression or magnetic resonance imaging (MRI). The application of MRI is limited by image distortion and a lack of electron density information. The standard supine position not only exposes the tumor to RT non-homogenously, it can cause damage to the neighboring benign tissues. Here, we compare the effectiveness of both the prone and supine positions in breast cancer RT and various aspects of breast cancer treatment planning using MRI and CT.
Whole breast and regional nodal irradiation in prone versus supine position in left sided breast cancer. [2018]Prone whole breast irradiation (WBI) leads to reduced heart and lung doses in breast cancer patients receiving adjuvant radiotherapy. In this feasibility trial, we investigated the prone position for whole breast + lymph node irradiation (WB + LNI).
Implementing stereotactic accelerated partial breast irradiation using magnetic resonance guided radiation therapy. [2021]Accelerated partial breast irradiation (APBI) seeks to reduce irradiated volumes and radiation exposure for patients while maintaining acceptable clinical outcomes. Magnetic resonance image-guided radiotherapy (MRgRT) provides excellent soft-tissue contrast for treatment localization, which can reduce setup uncertainty, thus reducing margins in the external beam setting. Additionally, stereotactic body radiotherapy (SBRT)-style regimens with high gradients can also be executed. This MR-guided stereotactic APBI (MRgS-APBI) approach can be utilized for a lower number of fractions and spare a greater volume of healthy tissues compared to conventional 3D external beam APBI.
Setup accuracy for prone and supine whole breast irradiation. [2018]To evaluate cone-beam computed tomography (CBCT) based setup accuracy and margins for prone and supine whole breast irradiation (WBI).
5-Year Outcomes of a Randomized Trial Comparing Prone and Supine Whole Breast Irradiation in Large-Breasted Women. [2021]Prone position for whole breast irradiation (WBI) results in lower rates of toxicity and reduced ipsilateral mean lung and heart doses. No randomized trials comparing toxicity and cosmesis at 5 years with prone and supine positioning are available.
Estimation of secondary cancer projected risk after partial breast irradiation at the 1.5 T MR-linac. [2022]For patients treated with partial breast irradiation (PBI), potential long-term treatment-related toxicities are important. The 1.5 T magnetic resonance guided linear accelerator (MRL) offers excellent tumor bed visualization and a daily treatment plan adaption possibility, but MRL-specific electron stream and return effects may cause increased dose deposition at air-tissue interfaces. In this study, we aimed to investigate the projected risk of radiation-induced secondary malignancies (RISM) in patients treated with PBI at the 1.5 T MRL.
Single dose partial breast irradiation using an MRI linear accelerator in the supine and prone treatment position. [2022]In selected patients with early-stage and low-risk breast cancer, an MRI-linac based treatment might enable a radiosurgical, non-invasive alternative for current standard breast conserving therapy.
[Treatment planning with functional MRI]. [2018]The aim of magnetic resonance imaging (MRI) guided radiotherapy is high precision in treatment delivery. With new developments it is possible to focus the high dose irradiation on the tumor while sparing the surrounding tissue. The achievements in precision of the treatment planning and delivery warrant equally precise tumor definition.
Magnetic Resonance Image Guided Radiation Therapy for External Beam Accelerated Partial-Breast Irradiation: Evaluation of Delivered Dose and Intrafractional Cavity Motion. [2022]To use magnetic resonance image guided radiation therapy (MR-IGRT) for accelerated partial-breast irradiation (APBI) to (1) determine intrafractional motion of the breast surgical cavity; and (2) assess delivered dose versus planned dose.