Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-03-01 @ 5:53 PM
Study NCT ID:
NCT02422550
Status:
RECRUITING
Last Update Posted:
2025-10-22
First Post:
2015-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging Acquisition and Analysis Methods for Optimization of MRI Radiation Oncology Simulation and Response Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 637}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-21', 'studyFirstSubmitDate': '2015-04-14', 'studyFirstSubmitQcDate': '2015-04-16', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluate the feasibility of new MRI or CT applications', 'timeFrame': '5 years', 'description': 'MRI or CT acquisition and analysis methods for radiotherapy planning or tumor response assessment during radiotherapy.'}]}, 'conditionsModule': {'keywords': ['MRI', '15-073', 'participants undergoing radiation therapy'], 'conditions': ['Radiation Therapy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://one.mskcc.org/sites/pub/Pages/default.aspx', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': "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.\n\nParticipating 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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be participants undergoing radiation therapy in the Department of Radiation Oncology, optional normal volunteers, or a combination thereof.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women age 18 or older\n\nExclusion Criteria:\n\n* Anyone who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Diseases Screening Questionnaire\n* Participants/volunteers with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field\n* Female participants/volunteers who are pregnant or nursing\n* Participants/Volunteers who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety\n* Participants/Volunteers from the vulnerable population, as defined by 45 CFR 46.\n* Participants at higher risk due to age, frailty, or the emergent nature of their condition.'}, 'identificationModule': {'nctId': 'NCT02422550', 'briefTitle': 'Imaging Acquisition and Analysis Methods for Optimization of MRI Radiation Oncology Simulation and Response Assessment', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '15-073'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'participants undergoing radiation therapy & normal volunteers', 'description': 'Protocol participation will consist of one or more research MRI or CT exams not to exceed 45 minutes.', 'interventionNames': ['Device: MRI or CT']}], 'interventions': [{'name': 'MRI or CT', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['participants undergoing radiation therapy & normal volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nancy Lee, MD', 'role': 'CONTACT', 'phone': '212-639-3341'}], 'facility': 'Memorial Sloan Kettering Basking Ridge (Consent only)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nancy Lee, MD', 'role': 'CONTACT', 'phone': '212-639-3341'}], 'facility': 'Memorial Sloan Kettering Monmouth (Consent only)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nancy Lee, MD', 'role': 'CONTACT', 'phone': '212-639-3341'}], 'facility': 'Memorial Sloan Kettering Bergen (Consent only )', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nancy Lee, MD', 'role': 'CONTACT', 'phone': '212-639-3341'}], 'facility': 'Memorial Sloan Kettering Commack (Consent Only)', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nancy Lee, MD', 'role': 'CONTACT', 'phone': '212-639-3341'}], 'facility': 'Memorial Sloan Kettering Westchester (Consent only)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nancy Lee, MD', 'role': 'CONTACT', 'phone': '212-639-3341'}, {'name': 'Simon Powell, MD', 'role': 'CONTACT', 'phone': '212-639-6072'}, {'name': 'Nancy Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Uniondale', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nancy Lee, MD', 'role': 'CONTACT', 'phone': '212-639-3341'}], 'facility': 'Memorial Sloan Kettering Nassau (Consent only)', 'geoPoint': {'lat': 40.70038, 'lon': -73.59291}}], 'centralContacts': [{'name': 'Nancy Lee, MD', 'role': 'CONTACT', 'phone': '212-639-3341'}, {'name': 'Simon Powell, MD', 'role': 'CONTACT', 'phone': '212-639-6072'}], 'overallOfficials': [{'name': 'Nancy Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}