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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01359267
First received: May 20, 2011
Last updated: March 3, 2014
Last verified: March 2014
  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:


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: March 2016
Estimated Primary Completion Date: March 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: University of Chicago
ClinicalTrials.gov Identifier: NCT01359267     History of Changes
Other Study ID Numbers: 11-0032
Study First Received: May 20, 2011
Last Updated: March 3, 2014
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 July 22, 2014