NCT02422550

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
837

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Apr 2015Apr 2027

Study Start

First participant enrolled

April 9, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

12 years

First QC Date

April 14, 2015

Last Update Submit

March 2, 2026

Conditions

Keywords

MRI15-073participants undergoing radiation therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 years

Study Arms (1)

participants undergoing radiation therapy & normal volunteers

Protocol participation will consist of one or more research MRI or CT exams not to exceed 45 minutes.

Device: MRI or CT

Interventions

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.

participants undergoing radiation therapy & normal volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be participants undergoing radiation therapy in the Department of Radiation Oncology, optional normal volunteers, or a combination thereof.

You may qualify if:

  • Men and women age 18 or older

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Consent only)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Consent only )

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Commack (Consent Only)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Consent only)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

Study Officials

  • Nancy Lee, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Lee, MD

CONTACT

Simon Powell, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 21, 2015

Study Start

April 9, 2015

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

March 3, 2026

Record last verified: 2026-03

Locations