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

ConditionHead and Neck Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Unable to tolerate diffusion weighted (DW)-MRI or DCE-MRI

Having an estimated glomerular filtration rate (GFR) < 60 ml/min/1.73 m²

Contraindication to MRI (e.g. non-MRI compatible metallic implants)

Pregnant females and cognitively impaired patients

Trial design

Design model

Parallel

Treatments tested in this trial

Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Procedure/Surgery
Undergo DCE-MRI
Questionnaire Administration
Other intervention
Ancillary studies

Treatment groups

1,400 Participants

are divided into 4 treatment groups

Group A: Cohort 1 (DCE-MRI)Experimental treatment 2 interventions

Group B: Cohort 2 (DCE-MRI)Experimental treatment 2 interventions

Group C: Cohort 3 (DCE-MRI)Experimental treatment 2 interventions

Group D: Cohort 4 (DCE-MRI)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

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

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

Time frame

5 years

Secondary outcomes

Dose-Response Relationships Between DCE-MRI Derived Imaging Biomarkers and Subsequent Development of Osteoradionecrosis (ORN)

Voxel-by-voxel correlation of delivered radiation dose to mandible and DCE-MRI parameter changes determined to establish a dose-biomarker response relationship.

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

National Institute of Dental and Craniofacial Research (NIDCR)