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Not Yet Recruiting NCT07659678

CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Head and Neck Squamous Cell Carcinoma HNSCC

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 90
Sponsor: Washington University School of Medicine

Location: Washington University School of Medicine St Louis Missouri

Summary

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07659678). StuddyBuddy aggregates publicly available trial information.