CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma (NCT07659678) | Clinical Trial Compass
Not Yet RecruitingPhase 2
CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma
United States90 participantsStarted 2026-08-31
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Timeframe: Enrollment until date of completion of follow-up, date of disease progression, or time of death, whichever occurs first (estimated total time to be 12 months)
8
Cohort 2 only: Progression-free survival (PFS)
Timeframe: Start of anti-PD1 treatment to date of disease progression or death from any cause (total estimated time to be 12 months)
9
Cohort 2 only: Overall survival (OS)
Timeframe: Start of anti-PD1 treatment to date of death from any cause (total estimated time to be 12 months)