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Feasibility of Imaging in the Treatment of Patients With Advanced Head and Neck Cancer

Early Phase 1
Completed
Conditions
Head and Neck Cancer
Interventions
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Imaging99mTc-EC-DG-
Primary Outcome Measures
NameTimeMethod
Persistent Disease within 6 months of CRT6 months
Secondary Outcome Measures
NameTimeMethod
Persistent Disease within 2 years of CRT2 years

Trial Locations

Locations (1)

University of Chicago

🇺🇸

Chicago, Illinois, United States

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