Functional MRI in Finding Hypoxia in Patients Undergoing Chemotherapy and Radiation Therapy for Stage III or Stage IV Head and Neck Cancer
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III lymphoepithelioma of the nasopharynx, stage III lymphoepithelioma of the oropharynx, stage III verrucous carcinoma of the larynx, stage IV lymphoepithelioma of the nasopharynx, stage IV lymphoepithelioma of the oropharynx, stage IV verrucous carcinoma of the larynx, stage III basal cell carcinoma of the lip, stage IV basal cell carcinoma of the lip, stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage III inverted papilloma of the paranasal sinus and nasal cavity, stage III midline lethal granuloma of the paranasal sinus and nasal cavity, stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage IV inverted papilloma of the paranasal sinus and nasal cavity, stage IV midline lethal granuloma of the paranasal sinus and nasal cavity, tongue cancer
Study Type
Interventional
Study Phase
Phase 1
Study Design
Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: chemotherapy Type: Drug
Name: diagnostic laboratory biomarker analysis Type: Other
Name: tissue oxygen measurement Type: Other
Name: blood-oxygen-level-dependent functional magnetic resonance imaging Type: Procedure
Name: dynamic contrast-enhanced magnetic resonance imaging Type: Procedure
Name: magnetic resonance spectroscopic imaging Type: Procedure
Name: radiation therapy Type: Radiation
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Status: Recruiting
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a - 866-460-4673; 214-648-7097
Start Date
October 2008
Sponsors
Simmons Cancer Center
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page