RECRUITING

Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients with Oral Cavity or Skull Base Tumors

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 phase IV trial studies how well serial magnetic resonance imaging (MRI) after radiation therapy works in predicting radiation-induced changes in the normal tissue of patients with oral cavity or skull base tumors. Performing MRIs after radiation therapy for patients with oral cavity or skull base tumors may help to predict osteoradionecrosis (a change in non-cancerous tissue).

Official Title

Serial Magnetic Resonance Imaging of Longitudinal Radiotherapy-Attributable Normal Tissue Injury

Quick Facts

Study Start:2018-09-17
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04265430

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. * Patients with histologically proven malignant neoplasms of the oral cavity and skull base
  2. * Patients whom, currently or previously, dispositioned to treatment with radiotherapy
  3. * Patients with good performance status (Eastern Cooperative Oncology Group \[ECOG\] score 0-2)
  4. * Patients willing to give written informed consent
  1. * Patients unable to tolerate diffusion weighted (DW)-MRI or dynamic contrast-enhanced (DCE)-MRI or having an estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73m\^2
  2. * Patients with contraindication to MRI (e.g. non-MRI compatible metallic implants)

Contacts and Locations

Study Contact

Stephen Y. Lai
CONTACT
713-792-6920
sylai@mdanderson.org

Principal Investigator

Stephen Y Lai
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Stephen Y Lai, 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 Date2018-09-17
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2018-09-17
Study Completion Date2025-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Malignant Oral Cavity Neoplasm
  • Malignant Skull Base Neoplasm
  • Osteoradionecrosis