Malignant Oral Cavity Neoplasm, Malignant Skull Base Neoplasm, Osteoradionecrosis
Conditions
Brief summary
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).
Detailed description
PRIMARY OBJECTIVES: I. Demonstrate the feasibility of serial magnetic resonance (MR) imaging biomarkers for assessment of early, intermediate, and late radiotherapy-attributable physiologic alteration of tumor and normal tissues and the kinetics thereof. II. Develop MR-biomarker inclusive predictive models for development of radiotherapy-attributable normal tissue injury. III. Define dose-response relationships between imaging biomarkers and subsequent radiation-induced effects. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT I: Patients may receive a contrast agent intravenously (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. COHORT II: 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.
Interventions
OTHERContrast Agent
Given IV
PROCEDUREMagnetic Resonance Imaging
Undergo MRI
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiotherapy-attributable imaging for normal tissue injury | Up 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 biomarkers | Up 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 effects | Up 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 |
Countries
United States
Contacts
Primary ContactStephen Y. Lai
Outcome results
None listed