Using advanced MRI to diagnose osteoradionecrosis in head and neck cancer patients
Using Magnetic Resonance Imaging (MRI) to Assess Mandibular and Soft Tissue Responses to Radiation Therapy
This study is testing if a special type of MRI can help doctors find osteoradionecrosis in head and neck cancer patients who have received radiation therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03145077 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in diagnosing osteoradionecrosis (ORN) in patients with head and neck cancer who are undergoing radiation therapy. The study aims to determine if DCE-MRI can reliably predict ORN and to explore the relationship between imaging biomarkers and the development of ORN. Patients will undergo multiple DCE-MRI scans at various intervals before and after radiation treatment to monitor changes and assess treatment responses. The study also seeks to develop predictive models for tissue injury related to radiation therapy.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed head and neck cancer who are scheduled to receive external beam radiation therapy.
Not a fit: Patients with non-malignant conditions or those who are not undergoing radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis and management of osteoradionecrosis in head and neck cancer patients, potentially reducing complications and improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for similar diagnostic purposes, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willing and able to provide informed consent * Patients must have histologic evidence of malignant neoplasm that may have been obtained from the primary tumor or metastatic lymph node * Receipt of external beam radiation therapy (EBRT) with curative intent, with or without concomitant chemotherapy * Good performance status (Eastern Cooperative Oncology Group \[ECOG\] score 0-2) * Willing to comply with all study procedures; and * Willing to participate for the duration of the study * COHORT 1 (LONGITUDINAL) GROUP 1 (PRE-RADIATION): Subjects who are currently undergoing or scheduled to undergo treatment with radiotherapy with or without chemotherapy (induction or concurrent) with intent to eradicate the malignancy. Treatment will include the following: 1) primary or nodal disease adjacent to (within 2 cm) the mandible (i.e., likely to receive a dose of at least 50 Gy to some portion of the mandible volumes) and 2) \> 60% probability of survival for 3 years after treatment * COHORT 1 (LONGITUDINAL) GROUP 2 (POST-RADIATION): Subjects who were previously treated with radiotherapy with or without chemotherapy (induction or concurrent). Treatment will have included the following: 1) unilateral maximum mandible dose of \>= 60 Gy and a gradient of dose across the mandible of \>= 20 Gy, 2) oncological cure and now in disease surveillance; and 3) no clinically diagnosed ORN at the time of enrollment * COHORT 2 (ENRICHED): Subjects with recurrent and/or new head and neck cancer disease who will undergo re-irradiation to the head and neck with intent to eradicate the malignancy. Treatment will include the following: 1) any mandible dose of at least 50 Gy cumulative (initial and subsequent treatment); and 2) no clinically diagnosed ORN at the time of enrollment * COHORT 3 (EARLY ORN INTERVENTION): Subjects with clinically confirmed low-grade/early stage osteoradionecrosis requiring therapeutic (medical and/or dental surgery) intervention as diagnosed by a qualified clinician. Clinical staging of developing or existing ORN will be conducted using the CTCAE 4.0 (Common Terminology Criteria for Adverse Events) * COHORT 4 (SURGICAL INTERVENTION FOR ADVANCED ORN): Subjects with clinically confirmed high grade/high stage osteoradionecrosis requiring surgical intervention. Clinical staging of ORN will be conducted using the CTCAE 4.0 (Common Terminology Criteria for Adverse Events) Exclusion Criteria: * Unable to tolerate diffusion weighted (DW)-MRI or DCE-MRI * Having an estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73 m\^2 * Contraindication to MRI (e.g. non-MRI compatible metallic implants) * Pregnant females and cognitively impaired patients * Unable or unwilling to give written, informed consent to undergo MRI imaging * Claustrophobia * Unable to obtain imaging studies of adequate quality to assess imaging-based biomarkers * COHORT 1/GROUP 1: Previously treated with radiotherapy for a malignant neoplasm of the head and neck, excluding cutaneous lesions. Determination will be made by review of the radiation therapy plan and dosimetry map to evaluate mandible exposure to radiation * COHORT 1/GROUP 2: Previously treated with radiotherapy for a malignant neoplasm of the head and neck more than one time, excluding cutaneous lesions
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Stephen Lai — M.D. Anderson Cancer Center
- Study coordinator: Stephen> Lai
- Email: sylai@mdanderson.org
- Phone: 713-792-6920
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.