Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Diagnosing Osteoradionecrosis in Patients With Head and Neck Cancer That Is Primary, Has Come Back, or Has Spread to Other Places in the Body

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03145077
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dynamic Contrast-Enhanced Magnetic Resonance Imaging — PROCEDURE
    Undergo DCE-MRI
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

This trial studies how well dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) works in diagnosing osteoradionecrosis in patients with head and neck cancer that is primary, has come back, or has spread to other places in the body who are undergoing radiation therapy. DCE-MRI may help doctors to predict osteoradionecrosis in patient with head and neck cancer undergoing radiation therapy.

Key Dates

Start date
Mar 21, 2017
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
1,400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cohort 1 (DCE-MRI)
    Patients with newly diagnosed tumors undergo DCE-MRI within 4 weeks prior to the first radiation fraction, within 3-5 weeks after radiation start, and at 2, 6, 12, 24, and 36 months post radiation. Patients who were previously irradiated and are at various stages of oncologic follow-up undergo DCE-MRI for a total of 2-5 times at baseline and at 6, 12, 24, 36, and/or 48 months post radiation. Patients in the third or subsequent years post treatment may undergo subsequent yearly imaging studies.
  • Experimental: Cohort 2 (DCE-MRI)
    Patients undergo DCE-MRI within 4 weeks prior to the first re-radiation fraction, within 3-5 weeks after radiation start, and at 2, 6, 12, 24, and 36 months post radiation.
  • Experimental: Cohort 3 (DCE-MRI)
    Patients undergo DCE-MRI before and at 2 and 6 months post ORN treatment. Patients may undergo DCE-MRI during the mid-ORN treatment.
  • Experimental: Cohort 4 (DCE-MRI)
    Patients undergo DCE-MRI within 4 weeks prior to and at 5-10 weeks and 12 months post surgery.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Stephen Y. Lai
[email protected]
713-792-6920
Stephen Y. Lai (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
M D Anderson Cancer Center· Houston, TX

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