CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine

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

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Washington University School of Medicine

Lead sponsor

National Cancer Institute (NCI)

Collaborator