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

Head and Neck Cancer Clinical Trial

Official title:

Predicting Treatment Response Based on Hypoxia in Head and Neck Cancers Using Non-Invasive Oxygen Sensitive MRI

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00896350
• Other study ID #: SCCC-02308
• Secondary ID: CDR0000637640NCI
• Status: Terminated
• Phase: Phase 1
• Start date: July 8, 2009
• Est. completion date: July 2012

Study information

• Verified date: February 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Hypoxia

Intervention

Drug:
• Standard Care Chemoradiation
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.

Locations

Country	Name	City	State
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI signal sensitivity to oxygen	MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE)	12 weeks
Primary	Tumor shrinkage and blood oxygen association	Association between tumor shrinkage and blood oxygen level dependent	12 weeks
Secondary	Correlate tumor hypoxia with patient prognosis and treatment response	Association between tumor hypoxia, patient prognosis, and treatment response.	12 weeks