MRI for Predicting Radiation Changes in Oral Cavity or Skull Base Tumors
This study is looking at how well serial Magnetic Resonance Imaging (MRI) can predict changes in normal tissues after radiation therapy for people with oral cavity or skull base tumors. You would receive a contrast agent (a special dye given through an IV) and undergo multiple MRI scans. Researchers hope to see if these MRIs can help predict osteoradionecrosis (bone damage caused by radiation) and other radiation-induced effects. To join, you must be over 18, have a good performance status (ECOG score 0-2, meaning you are fully active or can carry out light work), and have a histologically proven tumor of the oral cavity, oropharynx, or skull base. The study aims to understand the relationship between MRI findings and future radiation effects. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 425 participants, divided into two groups (cohorts).
- What's involved
- You would receive a contrast agent intravenously and undergo MRI scans at several time points, including before, during, and after radiation therapy or surgery, over a period of up to 3 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed for up to 3 years after completing radiation therapy or surgery, with primary endpoints measured up to 1 year.
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Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients With Oral Cavity or Skull Base Tumors
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Stephen Y Lai · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Radiotherapy-attributable imaging for normal tissue injuryUp to 1 year
Will correlate whether post-therapy alterations in the observed multi-parametric imaging features can be used as surrogate bio-markers of normal tissue injury
- Dose-response correlation between imaging biomarkersUp to 1 year
Penalized spline mixed regression will be used to characterize the induced functional relationships between the delivered dose and imaging biomarkers identified at each imaging time point. Doses for which 95% confidence interval estimates of mean trajectory fail to overlap will characterize ranges that yield significantly different levels of dose-dependent modulation.
- Dose-response correlation between subsequent radiation-induced effectsUp to 1 year
Penalized spline mixed regression will be used to characterize the induced functional relationships between the delivered dose and imaging biomarkers identified at each imaging time point. Doses for which 95% confidence interval estimates of mean trajectory fail to overlap will characterize ranges that yield significantly different levels of dosedependent modulation