CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma

Sponsor: Washington University School of Medicine

Sponsor score: 40

ClinicalTrials ID:NCT07659678

This study assesses the sensitivity and specificity of 64Cu-DOTA-ECL1i PET/CT imaging in HNSCC patients. Eligible participants include adults with locally advanced or recurrent/metastatic squamous cell carcinoma, with lesions ≥1.0 cm. Participants receive an IV injection of the novel tracer 64Cu-DOTA-ECL1i, followed by a saline flush, for precision imaging evaluation.

Patient Parameters

Program Overview

This is a prospective study to evaluate the sensitivity and specificity of Cu-64 DOTA-ECL1i PET/CT imaging to serve as a novel precision imaging tool for patients with head and neck squamous cell carcinoma (HNSCC).

Eligibility Criteria

Inclusion Criteria

  • Adult patient 18 years of age or older
  • Cohort 1: Newly diagnosed locally advanced T3-T4a, N0-3 and M0 squamous cell head and neck cancer scheduled to undergo standard of care surgery with or without neoadjuvant therapy OR Cohort 2: Suspected or biopsy proven recurrent/metastatic squamous cell head and neck cancer scheduled to undergo first-line anti-PD1 therapy. HPV status does not need to be known and both HPV+ and HPV- subjects are eligible to enroll
  • Lesion size of at least 1.0 cm in longest dimension by conventional imaging.
  • Able to give informed consent
  • Not currently pregnant or nursing: Female subjects 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 24 hour period immediately prior to administration of Cu-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 60 min (total time) of PET/CT imaging

Locations

FACILITYZIPCITYSTATE
Washington University School of Medicine63110St LouisMissouri

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