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NCT04265430

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

Recruiting now Phase 4 Last updated 14 November 2025
What this trial tests

Phase 4 trial testing Contrast Agent in Malignant Oral Cavity Neoplasm in 425 participants. Currently enrolling.

Timeline
17 September 2018
Primary endpoint
1 September 2031
1 September 2031

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 4
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposediagnostic
Enrollment425
Start date17 September 2018
Primary completion1 September 2031
Estimated completion1 September 2031
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Malignant Oral Cavity Neoplasm or Malignant Skull Base Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Hypomagnesemia and incidence of osteoradionecrosis in patients with head and neck cancers.
    Liu W, Qdaisat A, Zhou S, Fuller CD, et al · · 2021 · cited 4× · PMID 33094893 · DOI 10.1002/hed.26510
  2. Black bone MRI morphometry for mandibular cortical bone measurement in head and neck cancer patients: prospective method comparison with CT.
    van Dijk LV, Ventura J, Wahid KA, Zhu LL, et al · · 2026 · cited 3× · PMID 41702795 · DOI 10.1016/j.oooo.2025.12.013
  3. MRI Intensity Standardization Evaluation Design for Head and Neck Quantitative Imaging Applications
    Wahid KA, He R, McDonald BA, Anderson BM, et al · · 2021 · cited 1× · DOI 10.1101/2021.02.24.21252322

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Other trials of Contrast Agent

Trials testing the same drug.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

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Data sources for this page

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