Using MRI to predict radiation effects in patients with oral or skull base tumors
Official title: Serial Magnetic Resonance Imaging of Longitudinal Radiotherapy-Attributable Normal Tissue Injury
Run by M.D. Anderson Cancer Center · NCT04265430 · Data updated 2026-11-12
This study is testing if regular MRI scans can help predict how radiation treatment affects healthy tissues in patients with tumors in the mouth or skull base.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 425 (estimated) |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | September 17, 2018 |
| Main results expected | September 1, 2031 |
| Study ends | September 1, 2031 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT04265430 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with histologically confirmed malignant neoplasms of the oral cavity or skull base who are undergoing or have undergone radiotherapy.
✕Probably not a fit
Patients who cannot tolerate MRI procedures or have contraindications to MRI will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase IV trial investigates the effectiveness of serial magnetic resonance imaging (MRI) in predicting radiation-induced changes in normal tissues of patients with malignant tumors in the oral cavity or skull base. The study aims to assess the feasibility of MRI biomarkers to evaluate physiological alterations due to radiotherapy over time. Patients will undergo multiple MRI scans at various intervals after receiving radiation therapy to develop predictive models for normal tissue injury and understand dose-response relationships. The trial includes two cohorts, one receiving MRIs during radiation therapy and the other post-surgery.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict and manage radiation-induced injuries in patients undergoing treatment for oral cavity or skull base tumors.
How similar studies have gone: Other studies have explored the use of imaging biomarkers in predicting treatment effects, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: All Cohorts: * Patients older than 18 years of age * Patients with good performance status (ECOG score 0-2) * Patients willing to give written informed consent. Cohort 1 (Individuals without ORN or MRONJ): * Patients with histologically proven malignant neoplasms of the oral cavity, oropharynx or skull base. * Patients currently dispositioned to treatment with radiotherapy and/or antiresorptive or antiangiogenic medication therapy Cohort 2 (Individuals with ORN or MRONJ): * Patients with a clinical diagnosis of ORN or MRONJ following treatment for cancer * Patients previously dispositioned to treatment with radiotherapy and/or antiresorptive or antiangiogenic medication therapy Exclusion Criteria: * Patients unable to tolerate DW-MRI or DCE-MRI or having an estimated GFR \< 30ml/min/1.73m2. * Patients with contraindication to MRI (e.g. non-MRI compatible metallic implants)
Where it's running
-
M D Anderson Cancer Center
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Stephen Y Lai — M.D. Anderson Cancer Center
- Study coordinator: Stephen Y. Lai
- Email: sylai@mdanderson.org
- Phone: 713-792-6920
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.