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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01359267
Recruitment Status : Active, not recruiting
First Posted : May 24, 2011
Last Update Posted : October 11, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: 99mTc-EC-DG Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : April 19, 2011
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Persistent Disease within 6 months of CRT [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Persistent Disease within 2 years of CRT [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01359267

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Jonas De Souza, MD University of Chicago

Responsible Party: University of Chicago Identifier: NCT01359267     History of Changes
Other Study ID Numbers: 11-0032
First Posted: May 24, 2011    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site