Clinical trial NCT00896350: MRI in Finding Hypoxia in Patients Undergoing Chemo and Radiation for Head and Neck Cancer
Official title: Predicting Treatment Response Based on Hypoxia in Head and Neck Cancers Using Non-Invasive Oxygen Sensitive MRI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Head and Neck Cancer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2009-05-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: MRI signal sensitivity to oxygen
timeFrame: 12 weeks
measure: Tumor shrinkage and blood oxygen association
timeFrame: 12 weeks
Secondary outcomes:
measure: Correlate tumor hypoxia with patient prognosis and treatment response
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
state: Texas
Study officials:
affiliation: Simmons Cancer Center
name: Baran Sumer, MD
role: PRINCIPAL_INVESTIGATOR
References: