Imaging CCR2 Receptors With 64Cu-DOTA-ECL1i in Head and Neck Cancer

Study Overview
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Brief Summary
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CCR2 is a significant prognostic biomarker in head and neck cancer. Currently there is no clinical biomarker to study CCR2, its prognostic significance or to select patients for CCR2-targeted therapy and to monitor response to such therapy. The investigators have developed a CCR2 specific PET radiotracer based on the peptide, ECL1i (d(LGTFLKC)) and radiolabeled with 64Cu (64Cu-DOTA-ECL1i). The investigators have found that 64Cu-DOTA-ELC1i specific binding has been demonstrated in human head and neck cancer tissue.

Official Title
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Imaging CCR2 Receptors With 64Cu-DOTA-ECL1i in Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: 64Cu-DOTA-ECL1i


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient 18 years of age or older Cytology or biopsy-proven squamous cell head and neck cancer scheduled to be treated with standard of care surgery. Patients who are not surgical candidates should have adequate tissue from tumor biopsy for analysis of CCR2 Lesion size of at least 1.5 cm (treatment naïve) Able to give informed consent Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 14 hour period immediately prior to administration of 64Cu-DOTA-ECL1i is negative Exclusion Criteria: Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 2 years Unable to tolerate approximately 90 minutes (total time) of PET/CT imaging

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 64Cu-DOTA-ECL1i-PET/CT<br>-64CU-DOTA-ECL1i-PET/CT imaging consisting of a dynamic scan centered at the level of the known tumor followed by a limited body scan of the head/neck and upper chest will be performed | Drug: 64Cu-DOTA-ECL1i<br>* Will be produced by the Cyclotron Facility at Washington University School of Medicine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic quality of 64Cu-DOTA-ECL1i-PET/CT images as measured by assessment of overall image quality: 4 point scale | -Overall image quality will be graded on a 4 point scale with 1 being the worse and poor quality, not acceptable for diagnostic interpretation and 4 being good image quality, similar to routine clinical studies | At the time of scan (Day 1) | 
| Diagnostic quality of 64Cu-DOTA-ECL1i-PET/CT images as measured by presence of absence of abnormal 64Cu-DOT-ECL1i uptake in pathologically proven site of disease |  | At the time of scan (Day 1) | 
| CCR2 detection rate of 64Cu-DOTA-ECL1i-PET/CT as measured by IHC staining | -Intensity of CCR2 signal in IHC will be assessed by the study pathologist and categorized into 4 categories (0=absent/faint, 1=weak, 2=moderate, 3=strong). Any cells that stained positively with CCR2 will be assessed and the final score will be based on an overall assessment of CCR2 IHC on all of these cells. | At the time of standard of care surgery (estimated to be within 2 weeks of imaging) |