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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01359267
• Date of registration: 20/05/2011
• Primary sponsor: University of Chicago
• Public title: Feasibility of Imaging in the Treatment of Patients With Advanced Head and Neck Cancer
• Scientific 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
• Date of first enrolment: April 2011
• Target sample size: 20
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01359267
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Countries of recruitment

United States

Contacts

• Name: Rosalyn Williams

• Name: Ezra Cohen, MD
• Affiliation: University of Chicago

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Head and Neck Cancer

Intervention(s)

Drug: 99mTc-EC-DG

Primary Outcome(s)

Persistent Disease within 6 months of CRT [Time Frame: 6 months]

Secondary Outcome(s)

Persistent Disease within 2 years of CRT [Time Frame: 2 years]

Secondary ID(s)

11-0032

Source(s) of Monetary Support

Please refer to primary and secondary sponsors