CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma
Starting soon · Phase 2
Conditions studied: Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Head and Neck Squamous Cell Carcinoma HNSCC
In brief
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).
Key facts
- Study ID
- NCT07659678
- Run by
- Washington University School of Medicine
- People needed
- 90
- Starts
- 2026-08-31
- Expected to finish
- 2032-03-31
- Last updated by the study team
- 2026-06-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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