Imaging Acquisition and Analysis Methods for Optimization of MRI Radiation Oncology Simulation and Response Assessment

Study Overview
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Brief Summary
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Magnetic resonance imaging (MRI) is currently one of the standard diagnostic imaging methods used to diagnose tumor stage before treatment in the Radiation Oncology Department. It is also used to check responses to radiation after treatment. However, MRI isn't traditionally used in planning for radiation treatment or in checking treated tumor and tissue changes during radiation treatment. The goal is to find out the possible benefits of MRI imaging techniques in these settings of radiation treatment. The research aims are to study the possibility of using devices with new abilities such as the MR-Linac. The MR-Linac combines a radiation treatment machine with a diagnostic MRI scanner. This device will improve the quality of MRI-guided radiation treatment. The MR-Linac has functions that are currently not available in other combined imaging and radiation delivery devices. The MR-Linac does not provide additional imaging capabilities that are not currently available in other imaging devices. Participating in this study would NOT change the current treatment plans, this will allow the investigators to use the MRI methods in research and future patient care.

Detailed Description
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The purpose of this protocol is to demonstrate proof of concept and feasibility of new MRI hardware, pulse sequences and data analysis software to plan radiotherapy treatment and to assess tumor response to radiotherapy (only FDA approved hardware are allowed in this study). Efforts to develop, modify and evaluate new or existing MR imaging techniques must be a continuous practice with the goal of enhancing the use of MRI during radiation therapy. The investigators therefore anticipate an ongoing need for such a protocol and believe the ability to perform such studies is critical to the translation of new imaging technologies from concept to routine clinical use. Under this protocol, modifications to the following items may be tested: pulse sequence programs, radiofrequency coils, reconstruction and processing software, other MR system hardware and analysis software. A brief description of each of these items is described below. The potential risks associated with modifying each of these items, and the measures that will be taken to minimize these risks are described in subsequent sections. Given that performing MRI examinations during radiation therapy is not the current standard of care, no changes to radiation treatment plans, radiotherapy delivery or treatment recommendations or guidelines will be done based on the findings for any participants entered on this protocol.

Official Title
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Development and Evaluation of Imaging Acquisition and Analysis Methods for Optimization of MRI in Radiation Oncology Simulation, Treatment Planning, and Response Assessment

Conditions
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Radiation Therapy

Intervention / Treatment
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* Device: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women age 18 or older Exclusion Criteria: Anyone who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Diseases Screening Questionnaire Participants/volunteers with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field Female participants/volunteers who are pregnant or nursing Participants/Volunteers who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety Participants/Volunteers from the vulnerable population, as defined by 45 CFR 46. Participants at higher risk due to age, frailty, or the emergent nature of their condition.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| participants undergoing radiation therapy & normal volunteers<br> | Device: MRI<br>* Participants enrolled on this protocol may undergo multiple MRI examinations periodically over the course of their treatment and follow-up if they are participating in a development project related to tumor response assessment. Volunteers enrolled on this protocol may undergo multiple MRI examinations periodically for studies of reproducibility.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the feasibility of new MRI applications | MRI acquisition and analysis methods for radiotherapy planning or tumor response assessment during radiotherapy. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, 15-073, participants undergoing radiation therapy