Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients With Oral Cavity or Skull Base Tumors
NCT ID: NCT04265430
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
425 participants
INTERVENTIONAL
2018-09-17
2031-09-01
Brief Summary
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Detailed Description
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I. Demonstrate the feasibility of serial magnetic resonance (MR) imaging biomarkers for assessment of early, intermediate, and late radiotherapy-attributable physiologic alteration of tumor and normal tissues and the kinetics thereof.
II. Develop MR-biomarker inclusive predictive models for development of radiotherapy-attributable normal tissue injury.
III. Define dose-response relationships between imaging biomarkers and subsequent radiation-induced effects.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients may receive a contrast agent intravenously (IV) and then undergo an MRI over 45-60 minutes at baseline, 3-5 weeks after starting standard of care radiation therapy, and then at 2 months, 6 months, 12 months, and 3 years after completing radiation therapy.
COHORT II: Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, and at 5-10 weeks and 12 months after standard of care surgery.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Cohort I (MRI after radiation therapy)
Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, 3-5 weeks after starting standard of care radiation therapy, and then at 2 months, 6 months, 12 months, and 3 years after completing radiation therapy.
Contrast Agent
Given IV
Magnetic Resonance Imaging
Undergo MRI
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Cohort II (MRI after surgery)
Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, and at 5-10 weeks and 12 months after standard of care surgery.
Contrast Agent
Given IV
Magnetic Resonance Imaging
Undergo MRI
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Contrast Agent
Given IV
Magnetic Resonance Imaging
Undergo MRI
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients older than 18 years of age
* Patients with good performance status (ECOG score 0-2)
* Patients willing to give written informed consent.
Cohort 1 (Individuals without ORN or MRONJ):
* Patients with histologically proven malignant neoplasms of the oral cavity, oropharynx or skull base.
* Patients currently dispositioned to treatment with radiotherapy and/or antiresorptive or antiangiogenic medication therapy
Cohort 2 (Individuals with ORN or MRONJ):
* Patients with a clinical diagnosis of ORN or MRONJ following treatment for cancer
* Patients previously dispositioned to treatment with radiotherapy and/or antiresorptive or antiangiogenic medication therapy
Exclusion Criteria
* Patients with contraindication to MRI (e.g. non-MRI compatible metallic implants)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Stephen Y Lai
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Stephen Y. Lai
Role: primary
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2019-07862
Identifier Type: REGISTRY
Identifier Source: secondary_id
PA14-0807
Identifier Type: OTHER
Identifier Source: secondary_id
PA14-0807
Identifier Type: -
Identifier Source: org_study_id
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