Status:
RECRUITING
Quantitative Imaging Biomarker Prospective Validation of Dynamic Contrast-enhanced MRI as a Metric of Orodental Injury After Radiotherapy (QI-ProVE-MRI)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Orodental Injury
Eligibility:
All Genders
18+ years
Brief Summary
This research will focus on the prospective qualification and validation of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) candidate biomarkers (i.e., Ktrans and Ve) to assess the natu...
Detailed Description
This prospective observational study will acquire DCE-MRI data from 200 evaluable patients, specifically with an elevated dosimetric risk to assure an event rate of 20% by 36 months post-radiation, su...
Eligibility Criteria
Inclusion
- Provide signed and dated informed consent form.
- 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
- Unable to tolerate DW-MRI or DCE-MRI;
- 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.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2032
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06586892
Start Date
September 15 2025
End Date
December 30 2032
Last Update
September 23 2025
Active Locations (1)
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1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030