Lung Cancer (NSCLC)NCT07398209
GCC 2546- Motion Management
A study testing MRI in people with Lung Cancer (NSCLC) and Radiation, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC), Radiation
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2026to Apr 2029
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
Caitlin Eggleston, MPH, 410-369-5351, caitlineggleston@umm.edu
About this study
Official title: 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
- Conditions
- Lung Cancer (NSCLC), Radiation
- Being tested
- MRI
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Also called Fluoroscopy, 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.
| Study group | Role | What they receive |
|---|---|---|
| Imaging | Experimental | 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. Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start14 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Sawant, University of Maryland, Baltimore
- Investigators
- Amit Sawant, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398209
- Sponsor's protocol ID
- HP-00114565
- Status last verified
- Jun 2026
- First submitted
- 2 Feb 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining 4D MRI and 4DCT for Personalized Volumetric Motion Monitoring in Lung Radiation Therapy
- ClinicalTrials.gov ID
- NCT07398209
- Acronym / sponsor ID
- HP-00114565
- Conditions
- Lung Cancer (NSCLC), Radiation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 9 Feb 2026 (actual)
- 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging | Experimental | Other: MRIAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| MRIAlso: Fluoroscopy, Surface MonitoringBaseline 4D CT Simulation and 4S MRI with surface monitoring through EndoScout vest, followed by fluoroscopy and additional surface monitoring while undergoing daily radiation. | Other | Imaging |
Primary outcome
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
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 26 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Amit Sawant, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Lung Cancer (NSCLC) and Radiation, run by University of Maryland, Baltimore at 1 site 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 6 inclusion and 3 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 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Amit Sawant, PhD (410-328-6080, asawant@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 26 Jun 2026; AzTrials last refreshed its copy on 5 Nov 2026.