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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359267
• Other study ID #: 11-0032
• Status: Completed
• Phase: Early Phase 1
• Start date: April 19, 2011
• Est. completion date: September 15, 2015

Study information

• Verified date: May 2020
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 15, 2015
• Est. primary completion date: September 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistent Disease within 6 months of CRT		6 months
Secondary	Persistent Disease within 2 years of CRT		2 years