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New treatment option for Malignant Oral Cavity Neoplasm
Official title Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients With Oral Cavity or Skull Base Tumors
ClinicalTrials.gov ID: NCT04265430
What this study is testing
- What it's testing
- This phase IV trial studies how well serial magnetic resonance imaging (MRI) after radiation therapy works in predicting radiation-induced changes in the normal tissue of patients with oral cavity or skull base tumors. Performing MRIs after radiation therapy for patients with oral cavity or skull base tumors may help to predict osteoradionecrosis (a change in non-cancerous tissue).
- Phase 4: studies an already-approved treatment
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
- All Cohorts:
- 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.
You likely can't join if
- Patients unable to tolerate DW-MRI or DCE-MRI or having an estimated GFR \< 30ml/min/1.73m2.
- Patients with contraindication to MRI (e.g. non-MRI compatible metallic implants)
See the full eligibility criteria
- All Cohorts:
- 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
- Patients unable to tolerate DW-MRI or DCE-MRI or having an estimated GFR \< 30ml/min/1.73m2.
- Patients with contraindication to MRI (e.g. non-MRI compatible metallic implants)
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.