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DCE-MRI for Diagnosing Osteoradionecrosis in Head and Neck Cancer

This study is looking at how well a special type of MRI, called Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI), can help doctors find osteoradionecrosis (ORN) in people with head and neck cancer. ORN is a condition where bone tissue dies, often after radiation therapy. The study wants to see if DCE-MRI can predict who might develop ORN after radiation therapy, or if it can help monitor ORN and plan treatments. You may be able to join if you have head and neck cancer, have received radiation therapy, and are at least 18 years old. The main goal is to see how DCE-MRI results after radiation therapy relate to whether ORN develops within 5 years. The study is currently recruiting 1400 participants.

Study design
This is an interventional study, meaning participants will receive a specific procedure (DCE-MRI). It aims to enroll 1400 participants.
What's involved
You would undergo DCE-MRI scans multiple times, potentially before, during, and for several years after radiation therapy. You would also complete questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years to see if osteoradionecrosis develops.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03145077

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

Recruiting
NAAges 18+InterventionalDiagnostic
M.D. Anderson Cancer Center
~1,400 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:Dynamic Contrast-Enhanced Magnetic Resonance ImagingQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
DCE-MRI Derived Parameters Following External Beam Radiation Therapy (EBRT) and Subsequent Development of Osteoradionecrosis (ORN)
Measured over 5 years

Conditions

Head and Neck Cancer

Explore related trials

Malignant Head and Neck NeoplasmOsteoradionecrosis

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Stephen Lai · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Stephen> Lai
[email protected]
713-792-6920
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • DCE-MRI Derived Parameters Following External Beam Radiation Therapy (EBRT) and Subsequent Development of Osteoradionecrosis (ORN)5 years

    Spatiotemporal parameter maps extracted from patient DCE-MRI scans. Clinical staging of developing or existing ORN conducted according to the CTCAE 4.0.