MRI in Finding Hypoxia in Patients Undergoing Chemo and Radiation for Head and Neck Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Predicting Treatment Response Based on Hypoxia in Head and Neck Cancers Using Non-Invasive Oxygen Sensitive MRI

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: Standard Care Chemoradiation


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and neck Stage III or IV disease Measurable disease Scheduled to undergo standard treatment including radiation therapy and chemotherapy Participation on study # 092004-010 for tissue procurement PATIENT CHARACTERISTICS: ECOG performance status 0-2 Serum creatinine ≤ 1.5 OR creatinine clearance ≥ 40 Body mass index ≤ 34 Kg/m^2 Not claustrophobic No other contraindications to MRI (i.e., implanted pacemaker device) Not pregnant or nursing Negative pregnancy test No allergy to gadolinium PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BOLD MRI<br>Determine the amount of oxygen supply to tumors. | Drug: Standard Care Chemoradiation<br>* External beam radiation to the neck and tumor site of head and neck. Concurrent platinum based chemotherapy. External beam boost at discretion of treating physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI signal sensitivity to oxygen | MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE) | 12 weeks | 
| Tumor shrinkage and blood oxygen association | Association between tumor shrinkage and blood oxygen level dependent | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate tumor hypoxia with patient prognosis and treatment response | Association between tumor hypoxia, patient prognosis, and treatment response. | 12 weeks |