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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-19

Study Completion Date

2015-09-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Imaging

Group Type EXPERIMENTAL

99mTc-EC-DG

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No