Health TrialsbyHealthPanel

Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients With Oral Cavity or Skull Base Tumors

ConditionsMalignant Oral Cavity NeoplasmMalignant Skull Base NeoplasmOsteoradionecrosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients older than 18 years of age

Patients with good performance status (ECOG score 0-2)

Patients willing to give written informed consent.

Patients with histologically proven malignant neoplasms of the oral cavity, oropharynx or skull base.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Contrast Agent

    Other intervention

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

425 Participants
are divided into 2 treatment groups
Group A: Cohort I (MRI after radiation therapy)Experimental treatment 4 interventions
Group B: Cohort II (MRI after surgery)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Radiotherapy-attributable imaging for normal tissue injury

Will correlate whether post-therapy alterations in the observed multi-parametric imaging features can be used as surrogate bio-markers of normal tissue injury

Time frame
Up to 1 year
2

Dose-response correlation between imaging biomarkers

Penalized spline mixed regression will be used to characterize the induced functional relationships between the delivered dose and imaging biomarkers identified at each imaging time point. Doses for which 95% confidence interval estimates of mean trajectory fail to overlap will characterize ranges that yield significantly different levels of dose-dependent modulation.

Time frame
Up to 1 year
3

Dose-response correlation between subsequent radiation-induced effects

Penalized spline mixed regression will be used to characterize the induced functional relationships between the delivered dose and imaging biomarkers identified at each imaging time point. Doses for which 95% confidence interval estimates of mean trajectory fail to overlap will characterize ranges that yield significantly different levels of dosedependent modulation

Time frame
Up to 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now