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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE)

Safety Issue:

No

Principal Investigator

Baran Sumer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Simmons Cancer Center

Authority:

Unspecified

Study ID:

CDR0000637640

NCT ID:

NCT00896350

Start Date:

October 2008

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Head and Neck Neoplasms
  • Anoxia

Name

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390