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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02422550
Enrollment
937
Registered
2015-04-21
Start date
2015-04-09
Completion date
2027-04-01
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Therapy

Keywords

MRI, 15-073, participants undergoing radiation therapy

Brief summary

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

The purpose of this protocol is to demonstrate proof of concept and feasibility of new MRI or CT hardware, pulse sequences and data analysis software to plan and adapt 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 or CT imaging techniques must be a continuous practice with the goal of enhancing the use of MRI or CT 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 or CT 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.

Interventions

DEVICEMRI or CT

Participants enrolled on this protocol may undergo multiple MRI or CT 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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
evaluate the feasibility of new MRI or CT applications5 yearsMRI or CT acquisition and analysis methods for radiotherapy planning or tumor response assessment during radiotherapy.

Countries

United States

Contacts

CONTACTNancy Lee, MD
212-639-3341
CONTACTSimon Powell, MD
212-639-6072
PRINCIPAL_INVESTIGATORNancy Lee, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026