Head and Neck Cancer
Conditions
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.
Interventions
DRUG99mTc-EC-DG
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.
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Persistent Disease within 6 months of CRT | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Persistent Disease within 2 years of CRT | 2 years |
Countries
United States
Outcome results
None listed