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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Description

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.

Eligibility

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.

Study details
    Radiation Therapy

NCT02422550

Memorial Sloan Kettering Cancer Center

27 January 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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