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

This study is currently recruiting participants.
Verified June 2012 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
Ezra Cohen, MD, University of Chicago
ClinicalTrials.gov Identifier:
NCT01359267
First received: May 20, 2011
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Head and Neck Cancer
 Drug: 99mTc-EC-DG

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Persistent Disease within 6 months of CRT [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Persistent Disease within 2 years of CRT [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359267

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Rosalyn Williams     773-702-0712     rwilliam@medicine.bsd.uchicago.edu    
Principal Investigator: Ezra Cohen, MD            
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Ezra Cohen, MD University of Chicago
  More Information

No publications provided

Responsible Party: Ezra Cohen, MD, Associate Prof of Medicine, University of Chicago
ClinicalTrials.gov Identifier: NCT01359267     History of Changes
Other Study ID Numbers: 11-0032
Study First Received: May 20, 2011
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013