EF5 Compared With Other Methods of Detecting Oxygen Level... | NCT00049140 | Trialant
NCT00049140
Sponsor
David M. Brizel, MD
Status
Completed
Last Update Posted
Jul 25, 2014Estimated
Enrollment
8Actual
Phase
Phase 2
Conditions
Head and Neck Cancer
Interventions
EF5
bioluminescence
flow cytometry
immunohistochemistry staining method
biopsy
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00049140
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000257828
Secondary IDs
ID
Type
Description
Link
DUMC-3512-02-3
NCI-5929
Brief Title
EF5 Compared With Other Methods of Detecting Oxygen Levels in Tumor Cells of Patients With Head and Neck Cancer
Official Title
Pilot Study of the Relationship Between EF5 Uptake and Concentration of Oxygen-Related Metabolites in Head and Neck Cancer
Acronym
Not provided
Organization
Duke UniversityOTHER
Status Module
Record Verification Date
Feb 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2002
Primary Completion Date
Oct 2004Actual
Completion Date
Not provided
First Submitted Date
Nov 12, 2002
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 24, 2014
Last Update Posted Date
Jul 25, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
David M. Brizel, MD, Professor, Duke UniversitySponsor-Investigator
Lead Sponsor
David M. Brizel, MDOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors.
PURPOSE: Phase II trial to compare diagnostic procedures using EF5 to that of other methods of detecting oxygen levels in tumor cells of patients who have head and neck cancer.
Detailed Description
OBJECTIVES:
Determine the distribution, degree, and intrapatient and interpatient heterogeneity of hypoxia, as measured by EF5 binding in tumor tissue, in patients with head and neck cancer.
Determine the distribution and intrapatient and interpatient heterogeneity of CA9 expression, as measured immunohistochemically, in these patients.
Determine the distribution, concentration, and intrapatient and interpatient heterogeneity of glucose and lactate, as measured by bioluminescence imaging, in these patients.
Determine whether there is spatial coordination between concentrations of lactate and glucose and the location of tissue hypoxia in these patients.
Determine whether there is spatial coordination between the location of CA9 with hypoxia and/or lactate concentrations in these patients.
OUTLINE: Patients receive EF5 IV over 1-2.5 hours on day 1. Within 24-55 hours after EF5 infusion, patients undergo surgery.
Tumor tissue samples are examined for EF5 binding by immunohistochemistry, bioluminescence imaging, and flow cytometry.
Patients are followed at 1 month and then for survival.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 1 year.
Conditions Module
Conditions
Head and Neck Cancer
Keywords
stage I squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the larynx
stage I squamous cell carcinoma of the lip and oral cavity
stage I squamous cell carcinoma of the nasopharynx
stage I squamous cell carcinoma of the oropharynx
stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
stage II squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the nasopharynx
stage II squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
8Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
EF5
Experimental
This is a non randomised single arm pilot study.
Drug: EF5
Other: bioluminescence
Other: flow cytometry
Other: immunohistochemistry staining method
Procedure: biopsy
Interventions
Name
Type
Description
Arm Group Labels
Other Names
EF5
Drug
EF5
bioluminescence
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Heterogeneity of hypoxia as measured by EF5 binding at completion of accrual
One Year
Heterogeneity of CA9 expression by immunohistochemistry at completion of accrual
One year
Heterogeneity of glucose and lactate by bioluminescence imaging at completion of accrual
One Year
Spatial coordination as measured by EF5 binding at completion of accrual
One Year
Compare spatial coordination between the location of CA9 and hypoxia and/or lactate concentration at completion of accrual
One year
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the head and neck
Clinically detectable disease by physical examination or radiographic studies
Scheduled to undergo surgical resection of tumor or radiotherapeutic treatment
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
Karnofsky 70-100%
Life expectancy
Not specified
Hematopoietic
WBC greater than 3,000/mm^3
Platelet count greater than 100,000/mm^3
Hepatic
Bilirubin no greater than 1.5 mg/dL
Renal
Creatinine no greater than 1.8 mg/dL
Other
No allergy to IV contrast dye
No prior grade III or IV peripheral neuropathy
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 1 week after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
Not specified
Endocrine therapy
Not specified
Radiotherapy
See Disease Characteristics
Concurrent radiotherapy allowed
Surgery
See Disease Characteristics
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
David M. Brizel, MD
Duke University
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Duke Comprehensive Cancer Center
Durham
North Carolina
27710
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D006258
Head and Neck Neoplasms
D000077195
Squamous Cell Carcinoma of Head and Neck
D012468
Salivary Gland Neoplasms
Ancestor Terms
ID
Term
D009371
Neoplasms by Site
D009369
Neoplasms
D002294
Carcinoma, Squamous Cell
D002277
Carcinoma
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D005434
Flow Cytometry
D007150
Immunohistochemistry
D001706
Biopsy
Ancestor Terms
ID
Term
D002469
Cell Separation
D003584
Cytological Techniques
D019411
Clinical Laboratory Techniques
D019937
Diagnostic Techniques and Procedures
Browse Leaves
Not provided
Browse Branches
Not provided
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