GCC 2546- Motion Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
MRI
Other interventionBaseline 4D CT Simulation and 4S MRI with surface monitoring through EndoScout vest, followed by fluoroscopy and additional surface monitoring while undergoing daily radiation.
Treatment groups
44 Participants
are divided into 1 treatment groupGroup A: ImagingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 yearsSponsors and contacts
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Source ClinicalTrials.gov