Clinical trial · Interventional
Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients With Oral Cavity or Skull Base Tumors
Serial Magnetic Resonance Imaging of Longitudinal Radiotherapy-Attributable Normal Tissue Injury
NCT04265430CI-TRIAL-00112293recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase IV trial studies how well serial magnetic resonance imaging (MRI) after radiation therapy works in predicting radiation-induced changes in the normal tissue of patients with oral cavity or skull base tumors. Performing MRIs after radiation therapy for patients with oral cavity or skull base tumors may help to predict osteoradionecrosis (a change in non-cancerous tissue).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Oral Cavity Neoplasm | Malignant Oral Cavity Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Skull Base Neoplasm | Malignant Skull Base Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Osteoradionecrosis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast Agent | Other | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort I (MRI after radiation therapy)
- description
- Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, 3-5 weeks after starting standard of care radiation therapy, and then at 2 months, 6 months, 12 months, and 3 years after completing radiation therapy.
- interventionNames
- Other: Contrast Agent
- Procedure: Magnetic Resonance Imaging
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Cohort II (MRI after surgery)
- description
- Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, and at 5-10 weeks and 12 months after standard of care surgery.
- interventionNames
- Other: Contrast Agent
- Procedure: Magnetic Resonance Imaging
- Other: Quality-of-Life Assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.