Recruiting

DCE-MRI Biomarkers

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06586892

Conditions

Orodental Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiotherapy followed by chemotherapy

Study Details

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

Study ID

NCT06586892

Start date

Sep 15, 2025

Status verified date

Aug, 2026

Completion date

Dec 30, 2032

Anticipated

Primary completion date

Dec 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Interventions

Radiotherapy followed by chemotherapy

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.

Primary outcome measure

  • Overall Survival [ Time Frame: Up to 60 months ]

Central Contacts and Locations

Central contacts

Stephen Lai, MD,PHD

(713) 792-6528sylai@mdanderson.org

Locations

The University of Texas M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Stephen Lai, MD, PHD

713-792-6528sylai@mdanderson.org

Principal Investigator:

Stephen Lai, MD, PHD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-14.