- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07398209
GCC 2546- Motion Management
February 2, 2026 updated by: Amit Sawant, University of Maryland, Baltimore
Combining 4D MRI and 4DCT for Personalized Volumetric Motion Monitoring in Lung Radiation Therapy
The purpose of this study is to assess a real time motion tracking of lung tumors and important organs next to the tumor while breathing during a participant's radiation treatment.
This will be assessed through a four-dimensional magnetic resonance imaging (MRI) scan before starting your radiation treatment and x-ray fluoroscopy images that are taken during radiation
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amit Sawant, PhD
- Phone Number: 410-328-6080
- Email: asawant@som.umaryland.edu
Study Contact Backup
- Name: Caitlin Eggleston, MPH
- Phone Number: 410-369-5351
- Email: caitlineggleston@umm.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland Greenebaum Cancer Center
-
Contact:
- Caitlin Eggleston, MPH
- Phone Number: 410-369-5351
- Email: caitlineggleston@umm.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult (≥18 years) patients (both sexes) with histologically diagnosed Stage II-IIIb NSCLC
- Patients to be treated with definitive external beam photon radiotherapy with or without systemic therapy (e.g., chemotherapy, immunotherapy).
- No restrictions on number radiotherapy fractions, or location/number of lesions
- ECOG performance status ≤ 3
- Ability to undergo MRI scans
- Patient has signed informed consent document and agreed to study procedures
Exclusion Criteria:
- Pre-existing contraindications for MRI, such as any MRI-conditional or MRI-unsafe foreign objects within the body, non-removable ear cochlear or eye implant, aneurysm clip, cardiac pacemaker/wires, internal defibrillator, tissue expander, recent stent placement, penile prosthesis, medication patch, artificial limb, pregnancy, and claustrophobia
- Women who are pregnant or trying to get pregnant (self-reported)
- Pain in supine position or inability to raise arm above head in supine position
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Imaging
At baseline, patients will receive a 4D CT Simulation (standard of care) along with a 4D MRI with surface monitoring (research). During their radiation treatment, they will receive additional fluoroscopy imaging and surface monitoring. |
Baseline 4D CT Simulation and 4S MRI with surface monitoring through EndoScout vest, followed by fluoroscopy and additional surface monitoring while undergoing daily radiation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To investigate if time-resolved, multicycle volumetric motion modeling and monitoring gives improved spatiotemporal localization of the tumor target and OARs compared to current standard-of-care 4DCT-based motion modeling and monitoring
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Amit Sawant, PhD, University of Maryland, Baltimore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2026
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2029
Study Registration Dates
First Submitted
February 2, 2026
First Submitted That Met QC Criteria
February 2, 2026
First Posted (Actual)
February 9, 2026
Study Record Updates
Last Update Posted (Actual)
February 9, 2026
Last Update Submitted That Met QC Criteria
February 2, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00114565
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Radiation
-
Liverpool Heart and Chest Hospital NHS Foundation...Rampart Health, L.L.C.RecruitingRadiation Injuries | Radiation Exposure | Radiation Exposure to Operator | Radiation SafetyUnited Kingdom
-
Institute of Oncology LjubljanaCompletedRadiation Necrosis | Radiation Injury | Radiation-Induced ComplicationsSlovenia
-
Instituto de Cardiologia do Rio Grande do SulCompletedRadiation Injury | Exposure to Ionizing Radiation | Occupational Exposure to RadiationBrazil
-
National Cancer Institute (NCI)CompletedRadiation-Induced Neoplasms | Breast+Neoplasm+Radiation+Etiology | Thyroid+Neoplasm+Radiation+EtiologyUnited States
-
North Texas Veterans Healthcare SystemCompletedRadiation Protection | Radiation MonitoringUnited States
-
Maimonides Medical CenterWithdrawnRadiation Exposure | Radiation Exposure to OperatorUnited States
-
Affiliated Hospital to Academy of Military Medical...UnknownRadiation Injuries, ExperimentalChina
-
Pluristem Ltd.Unknown
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityNot yet recruitingChronic Radiation Injury
-
Neumedicines Inc.Department of Health and Human ServicesCompletedHematopoietic Syndrome Due to Acute Radiation SyndromeUnited States
Clinical Trials on MRI
-
Cambridge University Hospitals NHS Foundation TrustRecruitingBreast CancerUnited Kingdom
-
Seoul National University Bundang HospitalBayerCompletedTraumaKorea, Republic of
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)TerminatedOsteosarcoma | Ewing Sarcoma | Paget's DiseaseUnited States
-
Assistance Publique Hopitaux De MarseilleActive, not recruitingMultiple SclerosisFrance
-
Centre Hospitalier Universitaire de Saint EtienneLohmann & RauscherRecruitingLow Back Pain | Healthy VolunteerFrance
-
Abbott Medical DevicesCompletedAdverse Effect of MRI on an Implanted Pacemaker Lead | Adverse Effect of MRI on an Implanted PacemakerUnited States, Netherlands, Australia, Belgium, Finland
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingPatients with Atrial Fibrillation and Healthy Volunters
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)TerminatedAdult Anaplastic Astrocytoma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Recurrent Adult Brain TumorUnited States
-
University of EdinburghCompleted
-
Assistance Publique - Hôpitaux de ParisUnknownBrain Injury, Coma | Cardiac Arrest (CA) | Traumatic Brain Injury (TBI) | Aneurysmal Subarachnoid Hemorrhages (aSAH)France