About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- 64Cu-DOTA-ECL1i
Treatment groups
Locations
1Sponsors and collaborators
Washington University School of Medicine
Lead sponsor
National Cancer Institute (NCI)
Collaborator