Head and Neck Squamous Cell CarcinomaPhase 2NCT07659678
CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing 64Cu-DOTA-ECL1i in people with Head and Neck Squamous Cell Carcinoma and Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), run by Washington University School of Medicine at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Head and Neck Squamous Cell Carcinoma HNSCC
- What is being tested?
- 64Cu-DOTA-ECL1i
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2026to 31 May 2032
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Farrokh Dehdashti, MD, 314-362-1474, dehdashtif@wustl.edu
Yongjian Liu, PhD
About this study
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).
- Conditions
- Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Head and Neck Squamous Cell Carcinoma HNSCC
- Being tested
- 64Cu-DOTA-ECL1i
- Keywords
- Head and neck cancer, P16+ and P16-, PET, CCR2
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Recurrence, Neoplasm Metastasis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-DOTA-ECL1iDrug
Also called Copper Cu 64-DOTA-ECL1i, 64Cu-d(LGTFLKC), Cu-64 DOTA-ECL1i
64Cu-DOTA-ECL1i a novel PET imaging tracer that will be provided intravenously (IV) while participants will be positioned supine on the on the scanning table. The injection will be followed with saline flush.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Newly Diagnosed HNSCC who are scheduled to undergo surgical resection | Experimental | Cohort 1 will undergo 64Cu-DOTA-ECL1i positron emission tomography-computed tomography (PET/CT) once prior to scheduled standard of care (SOC) surgery and prior to any neoadjuvant therapy.
Participants will be followed up via a phone call or in-person visit 24 hours - 14 days after 64Cu-DOTA-ECL1i administration to assess for adverse events. Participants will be followed via medical chart review for standard of care clinical and radiological appointments. Receives: Drug: 64Cu-DOTA-ECL1i |
| Cohort 2: Recurrent/metastatic HNSCC who are candidates for first-line anti-PD1 therapy | Experimental | Cohort 2 subjects will undergo 64Cu-DOTA-ECL1i PET imaging twice, once at baseline prior to the start of anti-PD1 therapy and after 3 cycles of therapy (within 14 days of cycle 4 day 1).
Participants will be followed up via a phone call or in-person visit 24 hours - 14 days after baseline 64Cu-DOTA-ECL1i administration to assess for adverse events. Participants will be followed via medical chart review for standard of care clinical and radiological appointments. Receives: Drug: 64Cu-DOTA-ECL1i |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1 only: Semiquantitative 64Cu-DOTA-ECL1i PET/CT uptake
64Cu-DOTA-ECL1i PET uptake will be assessed using standardized update value maximum (SUVmax). SUV is a decay-corrected measurement of activity per volume of tissue (µCi/mL) divided by the average activity per unit mass in the entire body and/or tumor-to-normal-tissue-ratio. SUVmax is the highest measured uptake of a tracer of a lesion on a PET scan.
Measured: At baseline prior to scheduled surgery (estimated time frame: 1 day)
Cohort 1 only: Quantitative 64Cu-DOTA-ECL1i PET/CT uptake
Quantitative 64Cu-DOTA-ECL1i PET uptake will be assessed via a Logan/Patlak analysis to characterize the pharmacokinetics of the tumor. Logan/Patlak is a graphical analysis which uses linear regression to analyze the pharmacokinetics of tracers involving reversible uptake.
Measured: At time of surgery (total estimated time up to 14 days)
Cohort 2 only: Semiquantitative 64Cu-DOTA-ECL1i PET/CT uptake
64Cu-DOTA-ECL1i PET uptake will be assessed using standardized update value maximum (SUVmax). SUV is a decay-corrected measurement of activity per volume of tissue (µCi/mL) divided by the average activity per unit mass in the entire body) and/or tumor-to-normal-tissue-ratio. SUVmax is the highest measured uptake of a tracer of a lesion on a PET scan
Measured: At baseline (estimated time frame: 1 day)
Cohort 2 only: Quantitative 64Cu-DOTA-ECL1i PET/CT uptake
Quantitative 64Cu-DOTA-ECL1i PET uptake will be assessed via a Logan/Patlak analysis to characterize the pharmacokinetics of the tumor. Logan/Patlak is a graphical analysis which uses linear regression to analyze the pharmacokinetics of tracers involving reversible uptake.
Measured: At time of surgery (total estimated time up to 14 days)
Cohort 1 only: CCR2 expression in tumor tissue
CCR2 expression will be analyzed in tumor tissue specimens obtained from surgical specimens collected at resection and from archival biopsy specimens obtained prior to neoadjuvant therapy. CCR2 expression will be examined using flow cytometry and RT-PCR.
Measured: At time of surgery (total estimated time up to 14 days)
Cohort 2 only: Change in 64Cu-DOTA-ECL1i PET uptake from baseline to post-cycle 3 imaging
64Cu-DOTA-ECL1i PET uptake will be assessed using standardized update value maximum (SUVmax). SUV is a decay-corrected measurement of activity per volume of tissue (µCi/mL) divided by the average activity per unit mass in the entire body and/or tumor-to-normal-tissue-ratio. SUVmax is the highest measured uptake of a tracer of a lesion on a PET scan.
Measured: At baseline and post cycle 3 imaging (estimated time frame up to 9 weeks)
Cohort 2 only: Objective response
Objective response will be assessed according to RECIST 1.1. Objective response is defined as categorized as responder versus non-responder based on best overall response. Responder is defined as best overall response as complete or partial response. Non-responder is defined as best overall response as stable disease or progressive disease.
Measured: 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)
Cohort 2 only: Progression-free survival (PFS)
PFS is defined from anti-PD1 treatment start date to date of progression or date of death due to any cause. PFS will be analyzed by the Kaplan-Meier method.
Measured: Start of anti-PD1 treatment to date of disease progression or death from any cause (total estimated time to be 12 months)
Cohort 2 only: Overall survival (OS)
OS is defined from start of treatment to death due to any cause or last date of follow up. Alive patients are censored at the last follow-up otherwise. OS will be analyzed by the Kaplan-Meier method.
Measured: Start of anti-PD1 treatment to date of death from any cause (total estimated time to be 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 May 2032 (estimated)
- Study completion31 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Farrokh Dehdashti, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659678
- Sponsor's protocol ID
- 202605001
- Other IDs
- R01CA311209
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the trial, metadata collection, and supporting files will be shared via the digital repository Digital Commons@Becker.