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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Persistent Disease within 6 months of CRT

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Ezra Cohen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Food and Drug Administration

Study ID:

11-0032

NCT ID:

NCT01359267

Start Date:

April 2011

Completion Date:

April 2014

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Neoplasms

Name

Location

University of ChicagoChicago, Illinois  60637