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

The Washington University

Status and phase: Terminated; Phase 1

Conditions: Head and Neck Cancer

Treatments: Drug: 64Cu-DOTA-ECL1i

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04217057

1P41EB025815-01 (U.S. NIH Grant/Contract)

201912003

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

64Cu-DOTA-ECL1i-PET/CT

Experimental group

Description:

-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

Treatment:

Drug: 64Cu-DOTA-ECL1i