Predicting Treatment Response Based on Hypoxia in Head and Neck Cancers Using Non-Invasive Oxygen Sensitive MRI
Overview
- Phase
- Phase 1
- Intervention
- Standard Care Chemoradiation
- Conditions
- Head and Neck Cancer
- Sponsor
- University of Texas Southwestern Medical Center
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- MRI signal sensitivity to oxygen
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
RATIONALE: Diagnostic procedures, such as functional MRI, may help measure oxygen levels in tumor cells and may help in planning cancer treatment.
PURPOSE: This phase I trial is studying functional MRI to see how well it works in finding hypoxia in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.
Detailed Description
OBJECTIVES: * Determine the undertaken oxygen sensitive MRI for the detection of hypoxia in patients with Stage III-IV head and neck cancer. * Correlate MRI parameters with histology, gene expression, and plasma osteopontin. * Correlate tumor hypoxia measurements with patient prognosis and treatment response. OUTLINE: * Pre-therapy MRI: Patients undergo blood oxygen level dependant (BOLD) contrast MRI on room air breathing over 2 minutes and with oxygen gas over 15 minutes. Patients also undergo MR-spectroscopy over 15 minutes to measure choline and lactate markers, and dynamic contrast MRI with gadolinium contrast over 8 minutes. * Chemoradiotherapy: Patients receive platinum based chemotherapy every two weeks. Patients also undergo radiation therapy for 6 weeks. * Post-radiation MRI: Patients undergo MRI as before chemoradiotherapy. Blood and tumor samples are collected at baseline for biomarker analysis associated with tumor progression or response. After completion of study, patients are followed every 3 months for up to 1 year.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BOLD MRI
Determine the amount of oxygen supply to tumors.
Intervention: Standard Care Chemoradiation
Outcomes
Primary Outcomes
MRI signal sensitivity to oxygen
Time Frame: 12 weeks
MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE)
Tumor shrinkage and blood oxygen association
Time Frame: 12 weeks
Association between tumor shrinkage and blood oxygen level dependent
Secondary Outcomes
- Correlate tumor hypoxia with patient prognosis and treatment response(12 weeks)