- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07398209
GCC 2546- Motion Management
June 23, 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
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
- Recruiting
- 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 (Actual)
April 14, 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)
June 26, 2026
Last Update Submitted That Met QC Criteria
June 23, 2026
Last Verified
June 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.