Osteoradionecrosis Clinical Trial
Official title:
Serial Magnetic Resonance Imaging of Longitudinal Radiotherapy-Attributable Normal Tissue Injury
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).
PRIMARY OBJECTIVES: I. Demonstrate the feasibility of serial magnetic resonance (MR) imaging biomarkers for assessment of early, intermediate, and late radiotherapy-attributable physiologic alteration of tumor and normal tissues and the kinetics thereof. II. Develop MR-biomarker inclusive predictive models for development of radiotherapy-attributable normal tissue injury. III. Define dose-response relationships between imaging biomarkers and subsequent radiation-induced effects. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT I: Patients may receive a contrast agent intravenously (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. COHORT II: 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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00989820 -
Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis
|
Phase 2/Phase 3 | |
| Completed |
NCT01147315 -
ORN Study: Curative Treatment of Osteoradionecrosis (ORN) With Hybrid Bone Substitution
|
N/A | |
| Not yet recruiting |
NCT06055257 -
Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible
|
Phase 3 | |
| Recruiting |
NCT04934644 -
The Effect of Hyperbaric Oxygen Treatment in Patients With Osteoradionecrosis.
|
N/A | |
| Active, not recruiting |
NCT04009161 -
Osteoradionecrosis Rate in Patients Undergoing Radiotherapy for Head and Neck Cancer Treatment.
|
||
| Recruiting |
NCT02661139 -
Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction
|
||
| Recruiting |
NCT00760682 -
Hyperbaric Oxygen Treatment of Mandibular Osteoradionecrosis. A Randomized Clinical Study
|
Phase 2 | |
| Recruiting |
NCT05412849 -
Radiation Field, Dose and Fractionation Related to Mandibular Complications
|
||
| Completed |
NCT02368457 -
Management of Mandibular ORN: PENTO as Medical Treatment
|
Phase 4 | |
| Active, not recruiting |
NCT05325970 -
Clinical Registry of Long-Term Dental Outcomes in Head and Neck Cancer Patients
|
||
| Active, not recruiting |
NCT02057510 -
Observational Study of Dental Outcomes in Head and Neck Cancer Patients
|
||
| Completed |
NCT04717765 -
Photobiomodulation in Oral Lesions Resulting From Anti-neoplastic Prevention
|
N/A |