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Recruiting NCT07398209

GCC 2546- Motion Management

No phase Interventional Lung Cancer (NSCLC) Radiation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI.
Who it may be relevant to
Registry conditions: Lung Cancer (NSCLC), Radiation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Combining 4D MRI and 4DCT for Personalized Volumetric Motion Monitoring in Lung Radiation Therapy

Overview

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

Interventions

  • Other MRI
    Baseline 4D CT Simulation and 4S MRI with surface monitoring through EndoScout vest, followed by fluoroscopy and additional surface monitoring while undergoing daily radiation.

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Maryland Greenebaum Cancer Center — Baltimore

Identifiers

NCT: NCT07398209 · HP-00114565

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗