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

The University of Texas System (UT)

Status and phase: Terminated; Phase 1

Conditions: Head and Neck Cancer

Treatments: Drug: Standard Care Chemoradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT00896350

SCCC-02308

NCI-2011-02811 (Registry Identifier)

CDR0000637640 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

BOLD MRI

Experimental group

Description:

Determine the amount of oxygen supply to tumors.

Treatment:

Drug: Standard Care Chemoradiation