CCR2 PET Imaging for Head and Neck Squamous Cell Carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study evaluates the accuracy of Cu-64 DOTA-ECL1i PET/CT as a precision imaging method for head and neck squamous cell carcinoma. It enrolls adults with newly diagnosed locally advanced disease or suspected/confirmed recurrent/metastatic disease, and includes patients planned for surgery or first-line anti-PD1 therapy. Participants must have lesions at least 1 cm and meet standard eligibility criteria, including informed consent and non-pregnant status. The lead sponsor is Washington University School of Medicine, with collaboration from the NCI, and sites are in St. Louis.

Why it matters

Who can join: the full rules

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

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Farrokh Dehdashti, MD — Washington University School of Medicine
• Study coordinator: Farrokh Dehdashti, MD
• Email: dehdashtif@wustl.edu
• Phone: 314-362-1474

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.