Back to resultsFeasibility of Imaging in the Treatment of Patients With Advanced Head and Neck Cancer
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
99mTc-EC-DG
Sponsored by
About this trial
This is an interventional diagnostic trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria:
- Treatment naive patients with histologically proven cancer of the head and neck
- T4 primary tumor (all sites), N2 or N3 locoregional disease (all sites)
- At least one measurable site of disease
- At least 18 years of age
- Karnofsky performance status > or = 70% or ECOG <2
- Able to tolerate SPECT/CT imaging
- Adequate bone marrow function
- Adequate liver function
- Adequate renal function
- Written consent from patients
- Female patients of childbearing potential must have a negative pregnancy test within 0-7 days prior to the first SPECT study
Exclusion Criteria:
- Diabetics with insulin dependence or blood sugar levels >200 mg/dL prior to imaging
- Patient weight above the SPECT/CT table weight limit
- Pregnant and/or lactating female
- Unequivocal demonstration of metastatic disease
- Patients unwilling to or unable to comply with protocol
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Imaging
Arm Description
Outcomes
Primary Outcome Measures
Persistent Disease within 6 months of CRT
Secondary Outcome Measures
Persistent Disease within 2 years of CRT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01359267
Brief Title
Feasibility of Imaging in the Treatment of Patients With Advanced Head and Neck Cancer
Official Title
A Pilot Feasibility Study of 99mTc EC DG SPECT/CT Imaging in the Treatment Response Evaluation in Patients With Locally Advanced Head and Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 19, 2011 (Actual)
Primary Completion Date
September 15, 2015 (Actual)
Study Completion Date
September 15, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to obtain preliminary information on the potential of 99m Tc-EC-DG SPECT imaging to distinguish cancer from non cancer.
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
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Imaging
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
99mTc-EC-DG
Intervention Description
99mTc-EC-DG will be used before the SPECT/CT scans throughout the study to determine the its effectiveness. 20 mCi of 99mtc-EC-DG will be administered through a vein through a catheter. This will be done before the SPECT/CT scan at 4 weeks and 10 weeks.
Primary Outcome Measure Information:
Title
Persistent Disease within 6 months of CRT
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Persistent Disease within 2 years of CRT
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Treatment naive patients with histologically proven cancer of the head and neck
T4 primary tumor (all sites), N2 or N3 locoregional disease (all sites)
At least one measurable site of disease
At least 18 years of age
Karnofsky performance status > or = 70% or ECOG <2
Able to tolerate SPECT/CT imaging
Adequate bone marrow function
Adequate liver function
Adequate renal function
Written consent from patients
Female patients of childbearing potential must have a negative pregnancy test within 0-7 days prior to the first SPECT study
Exclusion Criteria:
Diabetics with insulin dependence or blood sugar levels >200 mg/dL prior to imaging
Patient weight above the SPECT/CT table weight limit
Pregnant and/or lactating female
Unequivocal demonstration of metastatic disease
Patients unwilling to or unable to comply with protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Everett Vokes, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility of Imaging in the Treatment of Patients With Advanced Head and Neck Cancer
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