MRI in Finding Hypoxia in Patients Undergoing Chemo and Radiation for Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Drug: Standard Care Chemoradiation
- Registration Number
- NCT00896350
- Lead Sponsor
- University of Texas Southwestern Medical Center
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BOLD MRI Standard Care Chemoradiation Determine the amount of oxygen supply to tumors.
- Primary Outcome Measures
Name Time Method MRI signal sensitivity to oxygen 12 weeks MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE)
Tumor shrinkage and blood oxygen association 12 weeks Association between tumor shrinkage and blood oxygen level dependent
- Secondary Outcome Measures
Name Time Method Correlate tumor hypoxia with patient prognosis and treatment response 12 weeks Association between tumor hypoxia, patient prognosis, and treatment response.
Trial Locations
- Locations (1)
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States