Actively Recruiting

Age: 18Years +
All Genders
NCT06586892

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

Led by M.D. Anderson Cancer Center · Updated on 2026-03-04

300

Participants Needed

1

Research Sites

380 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

N

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 natural history of osteoradionecrosis (ORN) and treatment for this devastating complication related to irradiation of head and neck cancers. The investigations will also include assessment of DCE-MRI candidate biomarkers for pre-qualification as quantitative imaging biomarkers of soft-tissue structures.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide signed and dated informed consent form.
  • Aged 18 years or older.
  • Have histologic evidence of malignant neoplasm from the primary tumor or metastatic lymph node.
  • Clinical decision to receive external beam radiation therapy with curative intent, with or without chemotherapy.
  • Good performance status (ECOG score 0-2) within 4 weeks before baseline imaging.
  • Willing to comply with all study procedures and participate for the duration of the study.
  • Elevated dosimetric risk defined by any of the following: D30>50Gy, V44 65 42%, or V58 65 25%.
Not Eligible

You will not qualify if you...

  • Unable to tolerate DW-MRI or DCE-MRI.
  • Estimated glomerular filtration rate (GFR) less than 30 ml/min/1.73 m2.
  • Contraindications to MRI such as non-MRI compatible metallic implants.
  • Pregnant females.
  • Unable or unwilling to give written informed consent for MRI imaging.
  • Claustrophobia.
  • Inability to obtain imaging studies of adequate quality to assess biomarkers.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

Loading map...

Research Team

S

Stephen Lai, MD,PHD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here