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New treatment option for Head and Neck Cancer
Official title 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
ClinicalTrials.gov ID: NCT03145077
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Unable to tolerate diffusion weighted (DW)-MRI or DCE-MRI
- Having an estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73 m\^2
- Contraindication to MRI (e.g. non-MRI compatible metallic implants)
- Pregnant females and cognitively impaired patients
- Unable or unwilling to give written, informed consent to undergo MRI imaging
- Claustrophobia
See the full eligibility 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): people who are currently undergoing or scheduled to undergo treatment with radiotherapy with or without chemotherapy (induction or concurrent) with intent to eradicate...
- COHORT 1 (LONGITUDINAL) GROUP 2 (POST-RADIATION): people who were previously treated with radiotherapy with or without chemotherapy (induction or concurrent). Treatment will have included the following: 1) unilateral...
- COHORT 2 (ENRICHED): people with recurrent and/or new head and neck cancer disease who will undergo re-irradiation to the head and neck with intent to eradicate the malignancy. Treatment will include the following: 1)...
- COHORT 3 (EARLY ORN INTERVENTION): people with clinically confirmed low-grade/early stage osteoradionecrosis requiring therapeutic (medical and/or dental surgery) intervention as diagnosed by a qualified clinician...
- COHORT 4 (SURGICAL INTERVENTION FOR ADVANCED ORN): people with clinically confirmed high grade/high stage osteoradionecrosis requiring surgical intervention. Clinical staging of ORN will be conducted using the CTCAE 4.0...
- Unable to tolerate diffusion weighted (DW)-MRI or DCE-MRI
- Having an estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73 m\^2
- Contraindication to MRI (e.g. non-MRI compatible metallic implants)
- Pregnant females and cognitively impaired patients
- Unable or unwilling to give written, informed consent to undergo MRI imaging
- Claustrophobia
- Unable to obtain imaging studies of adequate quality to assess imaging-based biomarkers
- COHORT 1/GROUP 1: Previously treated with radiotherapy for a malignant neoplasm of the head and neck, excluding cutaneous lesions. Determination will be made by review of the radiation therapy plan and dosimetry map to...
- COHORT 1/GROUP 2: Previously treated with radiotherapy for a malignant neoplasm of the head and neck more than one time, excluding cutaneous lesions
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.