RECRUITING

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

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Conditions

Orodental Injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09-15
Study Completion:2032-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06586892

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18 years or older.
  2. * Have histologic evidence of malignant neoplasm that may have been obtained from the primary tumor or metastatic lymph node.
  3. * Have a clinical decision made to receive external beam radiation therapy (EBRT) with curative intent, with or without concomitant chemotherapy.
  4. * Have a good performance status (ECOG score 0-2) evaluated during screening (4 weeks prior to baseline imaging).
  5. * Be willing to comply with all study procedures.
  6. * Be willing to participate for the duration of the study.
  7. * Have elevated dosimetric risk mainly characterized by any of the following criteria:
  8. * D30\>50Gy: 30% of the whole-mandible volume received a dose greater than 50 Gy
  9. * V44 ≥ 42%: at least 42% of the volume received a dose of 44 Gy or more or
  10. * V58 ≥ 25%: at least 25% of the volume received a dose of 58 Gy or more.
  1. * Having an estimated GFR \< 30 ml/min/1.73 m2;
  2. * Contraindication to MRI (e.g., non-MRI compatible metallic implants)
  3. * Pregnant females
  4. * Unable or unwilling to give written, informed consent to undergo MRI imaging.
  5. * Claustrophobia
  6. * Unable to obtain imaging studies of adequate quality to assess imaging-based biomarkers.

Contacts and Locations

Study Contact

Stephen Lai, MD,PHD
CONTACT
(713) 792-6528
sylai@mdanderson.org

Principal Investigator

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

Study Locations (Sites)

The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-15
Study Completion Date2032-12-30

Study Record Updates

Study Start Date2025-09-15
Study Completion Date2032-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Orodental Injury