Functional MRI in Finding Hypoxia in Patients Undergoing Chemotherapy and Radiation Therapy for Stage III or Stage IV Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT00896350|
Recruitment Status : Unknown
Verified March 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : May 11, 2009
Last Update Posted : March 1, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: chemotherapy Other: diagnostic laboratory biomarker analysis Other: tissue oxygen measurement Procedure: blood-oxygen-level-dependent functional magnetic resonance imaging Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: magnetic resonance spectroscopic imaging Radiation: radiation therapy||Phase 1|
- 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.
- 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 (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Masking:||None (Open Label)|
|Official Title:||Predicting Treatment Response Based on Hypoxia in Head and Neck Cancers Using Non-Invasive Oxygen Sensitive MRI|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||April 2010|
- MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE)
- Association between tumor shrinkage and blood oxygen level dependant (BOLD) MRI response
- Correlation of BOLD MRI response with oxygen breathing and DCE
- Correlation of BOLD MRI parameters with histological markers and therapeutic outcomes
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896350
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097|
|Principal Investigator:||Baran Sumer, MD||Simmons Cancer Center|