Serial Magnetic Resonance Imaging of Longitudinal Radiotherapy-Attributable Normal Tissue Injury
Who is this study for? Patients with oral cavity or skull base tumors
What treatments are being studied? Magnetic Resonance Imaging
Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
This phase IV trial studies how well serial magnetic resonance imaging (MRI) after radiation therapy works in predicting radiation-induced changes in the normal tissue of patients with oral cavity or skull base tumors. Performing MRIs after radiation therapy for patients with oral cavity or skull base tumors may help to predict osteoradionecrosis (a change in non-cancerous tissue).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients with histologically proven malignant neoplasms of the oral cavity and skull base
• Patients whom, currently or previously, dispositioned to treatment with radiotherapy
• Patients with good performance status (Eastern Cooperative Oncology Group \[ECOG\] score 0-2)
• Patients willing to give written informed consent
Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Stephen Y. Lai
sylai@mdanderson.org
713-792-6920
Time Frame
Start Date: 2018-09-17
Estimated Completion Date: 2031-09-01
Participants
Target number of participants: 425
Treatments
Experimental: Cohort I (MRI after radiation therapy)
Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, 3-5 weeks after starting standard of care radiation therapy, and then at 2 months, 6 months, 12 months, and 3 years after completing radiation therapy.
Experimental: Cohort II (MRI after surgery)
Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, and at 5-10 weeks and 12 months after standard of care surgery.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)