Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients With Oral Cavity or Skull Base Tumors

NCT04265430 | Recruiting Phase 4

• 2 other identifiers: PA14-0807NCI-2019-07862
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Radiotherapy-attributable imaging for normal tissue injury

  Will correlate whether post-therapy alterations in the observed multi-parametric imaging features can be used as surrogate bio-markers of normal tissue injury

  Up to 1 year

• Dose-response correlation between imaging biomarkers

  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.

  Up to 1 year

• Dose-response correlation between subsequent radiation-induced effects

  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

  Up to 1 year

Study Arms (2)

Cohort I (MRI after radiation therapy)

EXPERIMENTAL

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.

Other: Contrast Agent; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Cohort II (MRI after surgery)

EXPERIMENTAL

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.

Other: Contrast Agent; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Contrast Agent OTHER

Given IV

Also known as: Contrast, Contrast Drugs, contrast material, Contrast Medium

Cohort I (MRI after radiation therapy); Cohort II (MRI after surgery)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Cohort I (MRI after radiation therapy); Cohort II (MRI after surgery)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Cohort I (MRI after radiation therapy); Cohort II (MRI after surgery)

Questionnaire Administration OTHER

Ancillary studies

Cohort I (MRI after radiation therapy); Cohort II (MRI after surgery)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Mouth Neoplasms; Osteoradionecrosis

Interventions

Contrast Media; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Stephen Y Lai

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Y. Lai

CONTACT

713-792-6920; sylai@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: February 11, 2020
• Study Start: September 17, 2018
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2031
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (1)