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

The University of Chicago

Status and phase: Completed; Early Phase 1

Conditions: Head and Neck Cancer

Treatments: Drug: 99mTc-EC-DG

Study type: Interventional

Funder types: Other

Identifiers

NCT01359267

11-0032

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Imaging

Experimental group

Treatment:

Drug: 99mTc-EC-DG