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Observational Study of MRI for Orodental Injury After Radiotherapy

This study is looking at how dynamic contrast-enhanced MRI (magnetic resonance imaging) can help understand and track orodental injury (damage to the mouth and teeth) that can happen after radiation therapy for head and neck cancers. Researchers want to see if specific measurements from these MRI scans, called Ktrans and Ve, can be used as reliable indicators of this injury. You might be eligible if you are 18 or older, have a cancer diagnosis, and are planning to receive radiation therapy, with or without chemotherapy, for your head and neck cancer. The study aims to see if these MRI measurements can predict overall survival up to 60 months. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 300 participants. It will collect data from 200 patients who are at higher risk for orodental injury.
What's involved
If you agree, you will have 2 additional MRI scans within 2 weeks before your first visit. The first 90 participants who agree will have specific additional scans.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for overall survival for up to 60 months.

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NCT06586892

Quantitative Imaging Biomarker Prospective Validation of Dynamic Contrast-enhanced MRI as a Metric of Orodental Injury After Radiotherapy (QI-ProVE-MRI)

Recruiting
Not specifiedAges 18+Observational
M.D. Anderson Cancer Center
~300 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Radiotherapy followed by chemotherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival
Measured over Up to 60 months

Conditions

Orodental Injury

Explore related trials

Injury to KidneyMalignant Neoplasm

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Stephen Lai, MD,PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Stephen Lai, MD,PHD
[email protected]
(713) 792-6528
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Aged 18 years or older.
Have histologic evidence of malignant neoplasm that may have been obtained from the primary tumor or metastatic lymph node.
Have a clinical decision made to receive external beam radiation therapy (EBRT) with curative intent, with or without concomitant chemotherapy.
Have a good performance status (ECOG score 0-2) evaluated during screening (4 weeks prior to baseline imaging).
Be willing to comply with all study procedures.
Be willing to participate for the duration of the study.
Have elevated dosimetric risk mainly characterized by any of the following criteria:
D30\>50Gy: 30% of the whole-mandible volume received a dose greater than 50 Gy
V44 ≥ 42%: at least 42% of the volume received a dose of 44 Gy or more or
V58 ≥ 25%: at least 25% of the volume received a dose of 58 Gy or more.

Exclusion

Having an estimated GFR \< 30 ml/min/1.73 m2;
Contraindication to MRI (e.g., non-MRI compatible metallic implants)
Pregnant females
Unable or unwilling to give written, informed consent to undergo MRI imaging.
Claustrophobia
Unable to obtain imaging studies of adequate quality to assess imaging-based biomarkers.

What this trial measures

  • Overall SurvivalUp to 60 months