Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatment 99mtc-ec-dg
Sponsor University of Chicago
Start date April 2011
End date March 2017
Trial size 20 participants
Trial identifier NCT01359267, 11-0032

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacodynamics study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
99mtc-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.

Primary Outcomes

Measure
Persistent Disease within 6 months of CRT
time frame: 6 months

Secondary Outcomes

Measure
Persistent Disease within 2 years of CRT
time frame: 2 years

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Chicago.