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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: 99mTc-EC-DG

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imaging	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Persistent Disease within 6 months of CRT	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Persistent Disease within 2 years of CRT	2 years

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Everett Vokes, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2011
• Primary Completion (Actual): September 15, 2015
• Study Completion (Actual): September 15, 2015

Study Registration Dates

• First Submitted: May 20, 2011
• First Submitted That Met QC Criteria: May 23, 2011
• First Posted (Estimate): May 24, 2011

Study Record Updates

• Last Update Posted (Actual): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 11-0032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No