Clinical Trial: Using Magnetic Resonance Imaging (MRI) to Assess Normal Tissue and Tumor Response to Radiation Therapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Using Magnetic Resonance Imaging (MRI) to Assess Normal Tissue and Tumor Response to Radiation Therapy

Brief Summary: The goal of this research study is to learn if performing MRIs after radiation treatment for head and neck cancer can predict osteoradionecrosis (a change in non-cancerous tissue).

Detailed Summary:

Baseline Visit:

If participant agrees to take part in this study, participant will compete the following tests and procedures at the baseline visit:

  • Participant will have an MRI at the Center for Advanced Biomedical Imaging (CABI), in the South Campus Research Building at MD Anderson. It should take about 45-60 minutes to complete. Participant will be asked about any medical implants or metal that participant may have in participant's body.
  • Blood (about 2 tablespoons) will be drawn for routine testing.
  • Participant will complete 4 questionnaires about any symptoms of cancer and side effects from treatment participant may be having. Participant will also be asked about participant's daily life, participant's diet, and participant's ability to swallow and speak. It should take about 30 minutes to complete these questionnaires.

Study Groups:

Participant will be placed into a study group based on the status of the disease treatment:

  • Cohort 1, Group 1: Patients who will have radiation to treat head and neck cancer.
  • Cohort 1, Group 2: Patients who have already had radiation to treat head and neck cancer.
  • Cohort 2: Patients who have already had radiation to treat head and neck cancer and who will have additional radiation.
  • Cohort 3: Patients who have already had radiation and will have conservative treatment for early stage osteoradionecrosis.
  • Cohort 4: Patients who have already had radiation and will have s
    Sponsor: M.D. Anderson Cancer Center

    Current Primary Outcome: DCE-MRI Derived Parameters Following External Beam Radiation Therapy (EBRT) and Subsequent Development of Osteoradionecrosis (ORN) [ Time Frame: 5 years ]

    Spatiotemporal parameter maps extracted from patient DCE-MRI scans.

    Clinical staging of developing or existing ORN conducted according to the CTCAE 4.0.



    Original Primary Outcome: Same as current

    Current Secondary Outcome: Dose-Response Relationships Between DCE-MRI Derived Imaging Biomarkers and Subsequent Development of Osteoradionecrosis (ORN) [ Time Frame: 5 years ]

    Voxel-by-voxel correlation of delivered radiation dose to mandible and DCE-MRI parameter changes determined to establish a dose-biomarker response relationship.


    Original Secondary Outcome: Same as current

    Information By: M.D. Anderson Cancer Center

    Dates:
    Date Received: May 3, 2017
    Date Started: March 21, 2017
    Date Completion: March 2022
    Last Updated: May 4, 2017
    Last Verified: May 2017