Radiation TherapyNCT02422550
Imaging Acquisition and Analysis Methods for Optimization of MRI Radiation Oncology Simulation and Response Assessment
An observational study of Radiation Therapy, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radiation Therapy
- What is being tested?
- MRI or CT
- Type of treatment
- Medical device
- How many people
- 937 participants
- Where
- 7 sitesUnited States
- Study dates
- 9 Apr 2015to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be participants undergoing radiation therapy in the Department of Radiation Oncology, optional normal volunteers, or a combination thereof.
Who may be able to join
- Men and women age 18 or older
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nancy Lee, MD contact
Simon Powell, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, 07920
Nancy Lee, MD, 212-639-3341
- Recruiting
Memorial Sloan Kettering Commack (Consent Only)
Commack, New York, 11725
Nancy Lee, MD, 212-639-3341
- Recruiting
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604
Nancy Lee, MD, 212-639-3341
- Recruiting
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748
Nancy Lee, MD, 212-639-3341
- Recruiting
Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, 07645
Nancy Lee, MD, 212-639-3341
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Nancy Lee, MD, 212-639-3341
Simon Powell, MD, 212-639-6072
- Recruiting
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, 11553
Nancy Lee, MD, 212-639-3341
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Radiation Therapy
- Being tested
- MRI or CT
- Keywords
- MRI, 15-073, participants undergoing radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI or CTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| participants undergoing radiation therapy & normal volunteers | Protocol participation will consist of one or more research MRI or CT exams not to exceed 45 minutes. Receives: Device: MRI or CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the feasibility of new MRI or CT applications
MRI or CT acquisition and analysis methods for radiotherapy planning or tumor response assessment during radiotherapy.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study start9 Apr 2015
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation TherapyStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 937 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Lee, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422550
- Sponsor's protocol ID
- 15-073
- Status last verified
- Aug 2026
- First submitted
- 14 Apr 2015
- Last updated
- 11 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02422550
- Acronym / sponsor ID
- 15-073
- Conditions
- Radiation Therapy
- Keywords
- MRI, 15-073, participants undergoing radiation therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 937 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 9 Apr 2015 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participants undergoing radiation therapy & normal volunteers | – | Device: MRI or CTProtocol participation will consist of one or more research MRI or CT exams not to exceed 45 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be participants undergoing radiation therapy in the Department of Radiation Oncology, optional normal volunteers, or a combination thereof.
Key inclusion criteria (1 listed)
- Men and women age 18 or older
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI or CTParticipants 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. | Device | participants undergoing radiation therapy & normal volunteers |
Primary outcome
evaluate the feasibility of new MRI or CT applications
Time frame: 5 years
MRI or CT acquisition and analysis methods for radiotherapy planning or tumor response assessment during radiotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nancy Lee, MD contact
Simon Powell, MD contact
Nancy Lee, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Therapy, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Lee, MD (212-639-3341), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the feasibility of new MRI or CT applications (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.