Functional MRI in Finding Hypoxia in Patients Undergoing Chemotherapy and Radiation Therapy for Stage III or Stage IV Head and Neck Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00896350
First received: May 8, 2009
Last updated: February 26, 2011
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: chemotherapy
Other: diagnostic laboratory biomarker analysis
Other: tissue oxygen measurement
Procedure: blood-oxygen-level-dependent functional magnetic resonance imaging
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Procedure: magnetic resonance spectroscopic imaging
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Predicting Treatment Response Based on Hypoxia in Head and Neck Cancers Using Non-Invasive Oxygen Sensitive MRI

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE) [ Designated as safety issue: No ]
  • Association between tumor shrinkage and blood oxygen level dependant (BOLD) MRI response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of BOLD MRI response with oxygen breathing and DCE [ Designated as safety issue: No ]
  • Correlation of BOLD MRI parameters with histological markers and therapeutic outcomes [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: October 2008
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896350

Locations
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a    866-460-4673; 214-648-7097      
Sponsors and Collaborators
Simmons Cancer Center
Investigators
Principal Investigator: Baran Sumer, MD Simmons Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Regulatory Affairs Associate, Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
ClinicalTrials.gov Identifier: NCT00896350     History of Changes
Other Study ID Numbers: CDR0000637640, SCCC-02308
Study First Received: May 8, 2009
Last Updated: February 26, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III lymphoepithelioma of the nasopharynx
stage III lymphoepithelioma of the oropharynx
stage III verrucous carcinoma of the larynx
stage IV lymphoepithelioma of the nasopharynx
stage IV lymphoepithelioma of the oropharynx
stage IV verrucous carcinoma of the larynx
stage III basal cell carcinoma of the lip
stage IV basal cell carcinoma of the lip
stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage III inverted papilloma of the paranasal sinus and nasal cavity
stage III midline lethal granuloma of the paranasal sinus and nasal cavity
stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage IV inverted papilloma of the paranasal sinus and nasal cavity
stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
tongue cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Anoxia
Neoplasms by Site
Neoplasms
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014