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

Phase 1TerminatedNCT00896350

University of Texas Southwestern Medical Center10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

Standard Care ChemoradiationDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, United States

Outcomes

Primary Outcomes

MRI signal sensitivity to oxygen

MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE)

Time frame: 12 weeks

Tumor shrinkage and blood oxygen association

Association between tumor shrinkage and blood oxygen level dependent

Time frame: 12 weeks

Secondary Outcomes

Correlate tumor hypoxia with patient prognosis and treatment response

Association between tumor hypoxia, patient prognosis, and treatment response.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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