Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Diagnosing Osteoradionecrosis in Patients… (NCT03145077) | Clinical Trial Compass
RecruitingNot Applicable
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
United States1,400 participantsStarted 2017-03-21
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Willing and able to provide informed consent
* Patients must have histologic evidence of malignant neoplasm that may have been obtained from the primary tumor or metastatic lymph node
* Receipt of external beam radiation therapy (EBRT) with curative intent, with or without concomitant chemotherapy
* Good performance status (Eastern Cooperative Oncology Group \[ECOG\] score 0-2)
* Willing to comply with all study procedures; and
* Willing to participate for the duration of the study
* COHORT 1 (LONGITUDINAL) GROUP 1 (PRE-RADIATION): Subjects who are currently undergoing or scheduled to undergo treatment with radiotherapy with or without chemotherapy (induction or concurrent) with intent to eradicate the malignancy. Treatment will include the following: 1) primary or nodal disease adjacent to (within 2 cm) the mandible (i.e., likely to receive a dose of at least 50 Gy to some portion of the mandible volumes) and 2) \> 60% probability of survival for 3 years after treatment
* COHORT 1 (LONGITUDINAL) GROUP 2 (POST-RADIATION): Subjects who were previously treated with radiotherapy with or without chemotherapy (induction or concurrent). Treatment will have included the following: 1) unilateral maximum mandible dose of \>= 60 Gy and a gradient of dose across the mandible of \>= 20 Gy, 2) oncological cure and now in disease surveillance; and 3) no clinically diagnosed ORN at the time of enrollment
* COHORT 2 (ENRICHED): Subjects with recurrent and/or new head a…
What they're measuring
1
DCE-MRI Derived Parameters Following External Beam Radiation Therapy (EBRT) and Subsequent Development of Osteoradionecrosis (ORN)