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Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients With Oral Cavity or Skull Base Tumors

StatusRecruiting
PhasePhase 4
Started2018-09-17
View on ClinicalTrials.gov ↗

Amendment history

2026-05-19
Study Status v10
Re-verified, no change to tracked fields
2025-11-12
Study Status, Eligibility v9
Eligibility criteria+277 characters
Inclusion Criteria: All Cohorts: Patients witholder histologicallythan proven18 malignant neoplasmsyears of the oral cavity and skull base Patients whom, currently or previously, dispositioned to treatment with radiotherapyage Patients with good performance status (Eastern Cooperative Oncology Group [ECOG] score 0-2) Patients willing to give written informed consent. Cohort 1 (Individuals without ORN or MRONJ): Patients with histologically proven malignant neoplasms of the oral cavity, oropharynx or skull base. Patients currently dispositioned to treatment with radiotherapy and/or antiresorpti [...] [...]
2025-05-20
Study Identification, Study Status, Contacts/Locations v8
Primary completion date2025-04-30→2031-09-01
Completion date2025-04-30→2031-09-01
Study sitescontacts updated at 1 of 1 site
Study titlerevised
Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients withWith Oral Cavity or Skull Base Tumors
2024-10-28
Study Identification, Study Status, Contacts/Locations v7
Study sitescontacts updated at 1 of 1 site
Study titlerevised
Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients Withwith Oral Cavity or Skull Base Tumors
2024-05-13
Study Status v6
Re-verified, no change to tracked fields
Show 5 earlier versions
2023-10-04
Study Status v5
Primary completion date2023-09-30→2025-04-30
Completion date2023-09-30→2025-04-30
2023-06-06
2 amendments v3-v4
2 re-verifications since 2023-04-17, no change to tracked fields
2022-10-26
Study Status v2
Primary completion date2022-09-30→2023-09-30
Completion date2022-09-30→2023-09-30
2021-12-21
Study Identification, Study Status, Arms and Interventions, Outcome Measures, References v1
Primary completion date2021-09-30→2022-09-30
Completion date2021-09-30→2022-09-30
Primary endpoints3 entries, revised
Radiotherapy-attributable imaging for normal tissue injury
2020-02-10
Original filing
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).
Trial Details
NCT Number NCT04265430
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Malignant Oral Cavity Neoplasm, Malignant Skull Base Neoplasm, Osteoradionecrosis
Enrollment 425 participants
Start Date 2018-09-17
Primary Completion 2031-09-01 (estimated)
Study Completion 2031-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-22