Trial Summary
What is the purpose of this trial?This is a master protocol for a prospective Phase I-II study evaluating feasibility and efficacy of incorporating magnetic resonance imaging (MRI) simulation into the planning of radiation treatments.
What data supports the idea that MRI-Guided Radiation Therapy for Cancer is an effective treatment?The available research shows that MRI-Guided Radiation Therapy, also known as Image-Guided Radiotherapy (IGRT), is effective because it allows precise targeting of cancerous areas while minimizing damage to healthy tissue. For example, in the treatment of locally advanced rectal cancer, IGRT helps reduce side effects and long-term complications by accurately delivering radiation. Additionally, Intraoperative Radiation Therapy (IORT), a form of IGRT, has shown improved local control and survival rates in various cancers, including early breast cancer. This suggests that MRI-Guided Radiation Therapy can be a more effective option compared to traditional methods, as it enhances the accuracy and effectiveness of radiation delivery.123713
Is MRI-guided radiation therapy a promising treatment for cancer?Yes, MRI-guided radiation therapy is a promising treatment for cancer. It allows doctors to see tumors more clearly and adjust the treatment in real-time, which can lead to more precise targeting of the cancer while protecting healthy tissue. This approach is especially beneficial for cancers in areas like the abdomen and chest, where it can improve the accuracy of treatment.6891012
What safety data is available for MRI-guided radiation therapy for cancer?MRI-guided radiation therapy, often referred to as image-guided radiotherapy (IGRT), has been evaluated for safety in various studies. The ASTRO Safety White Paper Update highlights that IGRT is now widely used in clinical practice, emphasizing the importance of quality and patient safety. Studies have shown that IGRT is associated with fewer acute and chronic toxicities compared to some other techniques. However, one Phase III trial indicated worse overall survival in the IGRT arm, suggesting the need for further evaluation. Overall, IGRT is considered a safe and advanced radiation technique, particularly for prostate cancer, where it improves treatment accuracy and reduces toxicity.4571114
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for adults over 18 with certain cancers (like prostate, liver, and head & neck) who need radiation therapy. They should be relatively active (able to care for themselves), able to consent, and meet specific criteria listed in subprotocols. People can't join if they have allergies to MRI contrast agents or can't undergo an MRI.Inclusion Criteria
I am 18 years old or older.
My cancer needs radiation therapy.
I can take care of myself but might not be able to do active work.
Treatment Details
The study is testing the use of MRI simulation alongside standard radiation therapy in treating cancer. It's a two-phase study aiming to see how well this combination works and how feasible it is as a treatment planning method.
3Treatment groups
Experimental Treatment
Group I: Phase II MR Simulation Protocol: Track BExperimental Treatment2 Interventions
Adjusted Margin or / Dose Painted RT Based on Imaging of MR Simulator (e.g. biological imaging or higher resolution imaging)
Group II: Phase II MR Simulation Protocol: Track AExperimental Treatment2 Interventions
MR-only Radiation Therapy Simulation MRI-simulation and synthetic CT to plan treatment
Group III: Phase I MRI SimulationExperimental Treatment2 Interventions
This research study involves a screening period to determine eligibility.
- Radiation mapping to define the target for radiation.acquiring MR data at the specified timepoint in a patient's care plan and ability to identify the radiation target and develop a radiation therapy plan on the MR data.
Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇺🇸 Approved in United States as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇦 Approved in Canada as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇯🇵 Approved in Japan as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇳 Approved in China as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇭 Approved in Switzerland as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
Find a clinic near you
Research locations nearbySelect from list below to view details:
Brigham and Women HospitalBoston, MA
Dana Farber Cancer InstituteBoston, MA
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Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
References
Intraoperative radiation therapy. [2022]Intraoperative radiation therapy (IORT) is the delivery of irradiation at the time of an operation. This is performed by different techniques including intraoperative electron beam techniques and high-dose rate brachytherapy. IORT is usually given in combination with external-beam radiation therapy with or without chemotherapy and surgical resection. IORT excludes part or all dose-limiting sensitive structures, thereby increasing the effective dose to the tumor bed (and therefore local control) without significantly increasing normal tissue morbidity. Despite best contemporary therapy, high rates of local failure occur in patients with locally advanced or recurrent rectal cancer, retroperitoneal sarcoma, select gynecologic cancers, and other malignancies. The addition of IORT to conventional treatment methods has improved local control as well as survival in many disease sites in both the primary and locally recurrent disease settings. More recently, there has been interest in the use of IORT as a technique of partial breast irradiation for women with early breast cancer. Given newer and lower cost treatment devices, the use of IORT in clinical practice will likely grow, with increasing integration into the treatment of nonconventional malignancies. Optimally, phase III randomized trials will be carried out to prove its efficacy in these disease sites.
A (short) history of image-guided radiotherapy. [2022]Progress in radiotherapy is guided by the need to realize improved dose distributions, i.e. the ability to reduce the treatment volume toward the target volume and still ensuring coverage of that target volume in all dimensions. Poor ability to control the tumour's location limits the accuracy with which radiation can be delivered to tumour-bearing tissue. Image-guided radiation therapy (IGRT) aims at in-room imaging guiding the radiation delivery based on instant knowledge of the target location and changes in tumour volume during treatment. Advancements are usually not to be attributed to a single event, but rather a combination of many small improvements that together enable a superior result. Image-guidance is an important link in the treatment chain and as such a major factor in this synergetic process. A historic review shows that many of the so-called new developments are not so new at all, but did not make it into mainstream radiotherapy practice at that time. Recent developments in improved IT infrastructures, novel irradiation techniques, and better knowledge of functional and morphologic information may have created the need and optimal environment to revive the interest in IGRT.
Effectiveness of image-guided radiotherapy for locally advanced rectal cancer. [2011]Image-guided radiotherapy (IGRT) combines precise target visualization with optimal delivery of radiation dose to spare normal tissue from radiation and may potentially reduce side-effects and long-term treatment complications. We have assessed the effectiveness of IGRT for locally advanced rectal cancer.
Acute toxicity in prostate cancer patients treated with and without image-guided radiotherapy. [2021]Image-guided radiotherapy (IGRT) increases the accuracy of treatment delivery through daily target localisation. We report on toxicity symptoms experienced during radiotherapy treatment, with and without IGRT in prostate cancer patients treated radically.
Improvement in toxicity in high risk prostate cancer patients treated with image-guided intensity-modulated radiotherapy compared to 3D conformal radiotherapy without daily image guidance. [2021]Image-guided radiotherapy (IGRT) facilitates the delivery of a very precise radiation dose. In this study we compare the toxicity and biochemical progression-free survival between patients treated with daily image-guided intensity-modulated radiotherapy (IG-IMRT) and 3D conformal radiotherapy (3DCRT) without daily image guidance for high risk prostate cancer (PCa).
[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.
Dosimetric implications of inter- and intrafractional prostate positioning errors during tomotherapy : Comparison of gold marker-based registrations with native MVCT. [2022]For high-dose radiation therapy (RT) of prostate cancer, image-guided (IGRT) and intensity-modulated RT (IMRT) approaches are standard. Less is known regarding comparisons of different IGRT techniques and the resulting residual errors, as well as regarding their influences on dose distributions.
Two-and-a-half-year clinical experience with the world's first magnetic resonance image guided radiation therapy system. [2022]Magnetic resonance image guided radiation therapy (MR-IGRT) has been used at our institution since 2014. We report on more than 2 years of clinical experience in treating patients with the world's first MR-IGRT system.
A New Era of Image Guidance with Magnetic Resonance-guided Radiation Therapy for Abdominal and Thoracic Malignancies. [2022]Magnetic resonance-guided radiation therapy (MRgRT) offers advantages for image guidance for radiotherapy treatments as compared to conventional computed tomography (CT)-based modalities. The superior soft tissue contrast of magnetic resonance (MR) enables an improved visualization of the gross tumor and adjacent normal tissues in the treatment of abdominal and thoracic malignancies. Online adaptive capabilities, coupled with advanced motion management of real-time tracking of the tumor, directly allow for high-precision inter-/intrafraction localization. The primary aim of this case series is to describe MR-based interventions for localizing targets not well-visualized with conventional image-guided technologies. The abdominal and thoracic sites of the lung, kidney, liver, and gastric targets are described to illustrate the technological advancement of MR-guidance in radiotherapy.
Clinical implementation of magnetic resonance imaging guided adaptive radiotherapy for localized prostate cancer. [2022]Magnetic resonance-guided radiation therapy (MRgRT) has recently become available in clinical practice and is expected to expand significantly in coming years. MRgRT offers marker-less continuous imaging during treatment delivery, use of small clinical target volume (CTV) to planning target volume (PTV) margins, and finally the option to perform daily plan re-optimization.
Safety of image-guided radiotherapy in definitive radiotherapy for localized prostate cancer: a population-based analysis. [2022]Image-guided radiotherapy (IGRT) is a recommended advanced radiation technique that is associated with fewer acute and chronic toxicities. However, one Phase III trial showed worse overall survival in the IGRT arm. The purpose of this observational study is to evaluate the impact of IGRT on overall survival.
Magnetic Resonance Imaging-guided Adaptive Radiotherapy for Urological Cancers: What Urologists Should Know. [2022]Magnetic resonance imaging (MRI)-guided radiotherapy allows for online adaptation of the radiation plan on the basis of anatomical and functional changes during treatment. MRI-guided radiotherapy holds significant promise for broadening the therapeutic window for multiple urological cancers.
Recurrence and Survival Rates for 1400 Early Breast Tumors Treated with Intraoperative Radiation Therapy (IORT). [2022]Intraoperative radiotherapy (IORT) permits accurate delivery of radiation therapy directly to the tumor bed. We report local, regional, and distant recurrence data along with overall and breast cancer-specific survival for 1400 tumors treated with x-ray IORT.
Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]This updated report on image guided radiation therapy (IGRT) is part of a series of consensus-based white papers previously published by the American Society for Radiation Oncology addressing patient safety. Since the first white papers were published, IGRT technology and procedures have progressed significantly such that these procedures are now more commonly used. The use of IGRT has now extended beyond high-precision treatments, such as stereotactic radiosurgery and stereotactic body radiation therapy, and into routine clinical practice for many treatment techniques and anatomic sites. Therefore, quality and patient safety considerations for these techniques remain an important area of focus.