Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Diagnosing Osteoradionecrosis in Patients With Head and Neck Cancer That Is Primary, Has Come Back, or Has Spread to Other Places in the Body

Head and Neck Cancer Clinical Trial

Official title: Using Magnetic Resonance Imaging (MRI) to Assess Mandibular and Soft Tissue Responses to Radiation Therapy

Status Recruiting

Clinical Trial Summary

This trial studies how well dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) works in diagnosing osteoradionecrosis in patients with head and neck cancer that is primary, has come back, or has spread to other places in the body who are undergoing radiation therapy. DCE-MRI may help doctors to predict osteoradionecrosis in patient with head and neck cancer undergoing radiation therapy.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine whether DCE-MRI following external beam radiation therapy (EBRT) can be used to reliably predict osteoradionecrosis (ORN).

SECONDARY OBJECTIVES:

I. Define dose-response relationships between DCE-MRI derived imaging biomarkers and subsequent development of ORN.

II. Evaluate the use of DCE-MRI parameters to monitor ORN response to treatment.

III. Assess the use of DCE-MRI parameters in preoperative planning in advanced ORN subjects.

IV. Develop MRI-based biomarkers inclusive predictive models for development of radiotherapy-attributable tissue injury within the field of radiation.

V. Determine the association of patient-related outcomes (PROs) to clinical and imaging findings of tissue damage, such as the onset of ORN.

OUTLINE: Patients are assigned to 1 of 4 cohorts.

COHORT 1: Patients with newly diagnosed tumors undergo DCE-MRI within 4 weeks prior to the first radiation fraction, within 3-5 weeks after radiation start, and at 2, 6, 12, 24, and 36 months post radiation. Patients who were previously irradiated and are at various stages of oncologic follow-up undergo DCE-MRI for a total of 2-5 times at baseline and at 6, 12, 24, 36, and/or 48 months post radiation. Patients in the third or subsequent years post treatment may undergo subsequent yearly imaging studies.

COHORT 2: Patients undergo DCE-MRI within 4 weeks prior to the first re-radiation fraction, within 3-5 weeks after radiation start, and at 2, 6, 12, 24, and 36 months post radiation.

COHORT 3: Patients undergo DCE-MRI before and at 2 and 6 months post ORN treatment. Patients may undergo DCE-MRI during the mid-ORN treatment.

COHORT 4: Patients undergo DCE-MRI within 4 weeks prior to and at 5-10 weeks and 12 months post surgery. ;

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Osteoradionecrosis

• NCT number: NCT03145077
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Contact: Stephen> Lai
• Phone: 713-792-6920
• Email: sylai@mdanderson.org
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2017
• Completion date: March 31, 2024