Feasibility of Imaging in the Treatment of Patients With Advanced Head and Neck Cancer
This trial is active, not recruiting.
|Condition||head and neck cancer|
|Sponsor||University of Chicago|
|Start date||April 2011|
|End date||March 2017|
|Trial size||20 participants|
|Trial identifier||NCT01359267, 11-0032|
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.
|Endpoint classification||pharmacodynamics study|
|Intervention model||single group assignment|
Persistent Disease within 6 months of CRT
time frame: 6 months
Persistent Disease within 2 years of CRT
time frame: 2 years
Male or female participants at least 18 years old.
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
|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|
|Principal investigator||Jonas De Souza, MD|
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