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