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

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

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: Standard Care Chemoradiation

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BOLD MRI; Determine the amount of oxygen supply to tumors.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI signal sensitivity to oxygen	MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE)	12 weeks
Tumor shrinkage and blood oxygen association	Association between tumor shrinkage and blood oxygen level dependent	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlate tumor hypoxia with patient prognosis and treatment response	Association between tumor hypoxia, patient prognosis, and treatment response.	12 weeks

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Baran Sumer, MD, Simmons Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2009
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: May 8, 2009
• First Submitted That Met QC Criteria: May 8, 2009
• First Posted (Estimate): May 11, 2009

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Signs and Symptoms, Respiratory; Head and Neck Neoplasms; Hypoxia
• Other Study ID Numbers: SCCC-02308; CDR0000637640 (Registry Identifier: PDQ (Physician Data Query)); NCI-2011-02811 (Registry Identifier: CTRP (Clinical Trials Reporting System))