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

NCT ID: NCT00896350

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-08
• Study Completion Date: 2012-07-31

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

BOLD MRI

Determine the amount of oxygen supply to tumors.

Group Type: EXPERIMENTAL

Standard Care Chemoradiation

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Baran Sumer, MD

Role: PRINCIPAL_INVESTIGATOR

Simmons Cancer Center

Locations

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

CDR0000637640

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2011-02811

Identifier Type: REGISTRY

Identifier Source: secondary_id

SCCC-02308

Identifier Type: -

Identifier Source: org_study_id