Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04265430

Conditions

Malignant Oral Cavity Neoplasm

Malignant Skull Base Neoplasm

Osteoradionecrosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Contrast Agent

Magnetic Resonance Imaging

Quality-of-Life Assessment

Questionnaire Administration

Study Details

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).

Conditions

Malignant Oral Cavity Neoplasm

Malignant Skull Base Neoplasm

Osteoradionecrosis

Study ID

NCT04265430

Start date

Sep 17, 2018

Status verified date

May, 2026

Completion date

Sep 1, 2031

Anticipated

Primary completion date

Sep 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

425 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cohort I (MRI after radiation therapy)

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.

experimental: Cohort II (MRI after surgery)

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

Contrast Agent

Given IV

Magnetic Resonance Imaging

Undergo MRI

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Radiotherapy-attributable imaging for normal tissue injury [ Time Frame: Up to 1 year ]
  • Dose-response correlation between imaging biomarkers [ Time Frame: Up to 1 year ]
  • Dose-response correlation between subsequent radiation-induced effects [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Stephen Y. Lai

713-792-6920sylai@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Stephen Y. Lai

713-792-6920

Principal Investigator:

Stephen Y. Lai

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-22.