Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
1400
Participants Needed
1
Research Sites
531 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent
- Histologic evidence of malignant neoplasm from primary tumor or metastatic lymph node
- Receiving external beam radiation therapy (EBRT) with curative intent, with or without chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-2
- Willing to comply with all study procedures and participate for the study duration
- For Cohort 1 Group 1: Currently undergoing or scheduled for radiotherapy with or without chemotherapy aimed to eradicate cancer; primary or nodal disease within 2 cm of mandible; > 60% probability of 3-year survival
- For Cohort 1 Group 2: Previously treated with radiotherapy with unilateral mandible dose ≥ 60 Gy and dose gradient ≥ 20 Gy; in disease surveillance; no clinical osteoradionecrosis at enrollment
- For Cohort 2: Recurrent or new head and neck cancer undergoing re-irradiation with cumulative mandible dose ≥ 50 Gy; no clinical osteoradionecrosis at enrollment
- For Cohort 3: Clinically confirmed low-grade or early osteoradionecrosis requiring medical and/or dental surgery treatment
- For Cohort 4: Clinically confirmed high-grade or advanced osteoradionecrosis requiring surgical intervention
You will not qualify if you...
- Unable to tolerate diffusion weighted (DW)-MRI or dynamic contrast-enhanced MRI (DCE-MRI)
- Estimated glomerular filtration rate (GFR) less than 60 ml/min/1.73 m2
- Contraindications to MRI such as non-MRI compatible metallic implants
- Pregnant females or cognitively impaired patients
- Unable or unwilling to provide written informed consent for MRI imaging
- Claustrophobia
- Unable to obtain imaging studies of adequate quality for biomarker assessment
- For Cohort 1 Group 1: Previously treated with radiotherapy for head and neck malignant neoplasm excluding skin lesions
- For Cohort 1 Group 2: Previously treated more than once with radiotherapy for head and neck malignant neoplasm excluding skin lesions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Stephen> Lai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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