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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
Phase 4 trial testing Contrast Agent in Malignant Oral Cavity Neoplasm in 425 participants. Currently enrolling.
1 September 2031
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 425 |
| Start date | 17 September 2018 |
| Primary completion | 1 September 2031 |
| Estimated completion | 1 September 2031 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Contrast Agent — full drug profile →
- Magnetic Resonance Imaging
- Quality-of-Life Assessment
- Questionnaire Administration
Conditions studied
- Malignant Oral Cavity Neoplasm — all drugs for Malignant Oral Cavity Neoplasm →
- Malignant Skull Base Neoplasm — all drugs for Malignant Skull Base Neoplasm →
- Osteoradionecrosis — all drugs for Osteoradionecrosis →
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):
-
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT04265430
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04265430 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 14 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04265430.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing