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

Primary Purpose

Head and Neck Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Standard Care Chemoradiation
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BOLD MRI

Arm Description

Determine the amount of oxygen supply to tumors.

Outcomes

Primary Outcome Measures

MRI signal sensitivity to oxygen
MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE)
Tumor shrinkage and blood oxygen association
Association between tumor shrinkage and blood oxygen level dependent

Secondary Outcome Measures

Correlate tumor hypoxia with patient prognosis and treatment response
Association between tumor hypoxia, patient prognosis, and treatment response.

Full Information

First Posted
May 8, 2009
Last Updated
February 14, 2019
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00896350
Brief Title
MRI in Finding Hypoxia in Patients Undergoing Chemo and Radiation for Head and Neck Cancer
Official Title
Predicting Treatment Response Based on Hypoxia in Head and Neck Cancers Using Non-Invasive Oxygen Sensitive MRI
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Study Start Date
July 8, 2009 (Actual)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BOLD MRI
Arm Type
Experimental
Arm Description
Determine the amount of oxygen supply to tumors.
Intervention Type
Drug
Intervention Name(s)
Standard Care Chemoradiation
Intervention Description
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.
Primary Outcome Measure Information:
Title
MRI signal sensitivity to oxygen
Description
MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE)
Time Frame
12 weeks
Title
Tumor shrinkage and blood oxygen association
Description
Association between tumor shrinkage and blood oxygen level dependent
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Correlate tumor hypoxia with patient prognosis and treatment response
Description
Association between tumor hypoxia, patient prognosis, and treatment response.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baran Sumer, MD
Organizational Affiliation
Simmons Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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

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