Feasibility of Imaging in the Treatment of Patients With Advanced Head and Neck Cancer
Early Phase 1
Completed
- Conditions
- Head and Neck Cancer
- Interventions
- Drug: 99mTc-EC-DG
- Registration Number
- NCT01359267
- Lead Sponsor
- University of Chicago
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Imaging 99mTc-EC-DG -
- Primary Outcome Measures
Name Time Method Persistent Disease within 6 months of CRT 6 months
- Secondary Outcome Measures
Name Time Method Persistent Disease within 2 years of CRT 2 years
Trial Locations
- Locations (1)
University of Chicago
🇺🇸Chicago, Illinois, United States