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

NCT06586892 | Recruiting DMC

• 2 other identifiers: 2024-0406NCI-2024-06902
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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 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

Orodental Injury

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Up to 60 months

Interventions

Radiotherapy followed by chemotherapy BEHAVIORAL

Researchers would like to test the accuracy of the MRI data being used for this study. If you agree, you will have 2 additional MRI scans within 2 weeks before Visit 1. The first 90 participants who agree will be selected to have the following scans: * 35 participants will be scanned 2 times on one MRI device (Device #1). * 35 participants will be scanned 2 times on another MRI device (Device #2). * 20 participants will be scanned 1 time on both MRI devices (Device #1 and #2). If you agree and you are chosen, the study doctor will tell you if you will have scans on 1. or 2 MRI devices.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MD Anderson Cancer Center

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

Study Officials

• Stephen Lai, MD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Lai, MD,PHD

CONTACT

(713) 792-6528; sylai@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2032
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)