CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma

June 15, 2026 updated by: Washington University School of Medicine
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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
        • Contact:
        • Sub-Investigator:
          • Ningying Wu, MD, PhD
        • Sub-Investigator:
          • Douglas Adkins, MD
        • Sub-Investigator:
          • Yongjian Liu, PhD
        • Sub-Investigator:
          • Ryan Jackson, MD
        • Sub-Investigator:
          • Sidharth Puram, MD, PhD
        • Sub-Investigator:
          • Chieh-Yu Lin, MD, PhD
        • Sub-Investigator:
          • Richard Laforest, PhD
        • Sub-Investigator:
          • Ying Hwey Nai, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: Newly Diagnosed HNSCC who are scheduled to undergo surgical resection

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.
Drug: 64Cu-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.
Other Names:
  • Copper Cu 64-DOTA-ECL1i
  • 64Cu-d(LGTFLKC)
  • Cu-64 DOTA-ECL1i
Experimental: Cohort 2: Recurrent/metastatic HNSCC who are candidates for first-line anti-PD1 therapy

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.
Drug: 64Cu-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.
Other Names:
  • Copper Cu 64-DOTA-ECL1i
  • 64Cu-d(LGTFLKC)
  • Cu-64 DOTA-ECL1i

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 1 only: Semiquantitative 64Cu-DOTA-ECL1i PET/CT uptake
Time Frame: At baseline prior to scheduled surgery (estimated time frame: 1 day)
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.
At baseline prior to scheduled surgery (estimated time frame: 1 day)
Cohort 1 only: Quantitative 64Cu-DOTA-ECL1i PET/CT uptake
Time Frame: At time of surgery (total estimated time up to 14 days)
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.
At time of surgery (total estimated time up to 14 days)
Cohort 2 only: Semiquantitative 64Cu-DOTA-ECL1i PET/CT uptake
Time Frame: At baseline (estimated time frame: 1 day)
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
At baseline (estimated time frame: 1 day)
Cohort 2 only: Quantitative 64Cu-DOTA-ECL1i PET/CT uptake
Time Frame: At time of surgery (total estimated time up to 14 days)
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.
At time of surgery (total estimated time up to 14 days)
Cohort 1 only: CCR2 expression in tumor tissue
Time Frame: At time of surgery (total estimated time up to 14 days)
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.
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
Time Frame: At baseline and post cycle 3 imaging (estimated time frame up to 9 weeks)
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.
At baseline and post cycle 3 imaging (estimated time frame up to 9 weeks)
Cohort 2 only: Objective response
Time Frame: 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)
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.
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)
Time Frame: Start of anti-PD1 treatment to date of disease progression or death from any cause (total estimated time to be 12 months)
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.
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)
Time Frame: Start of anti-PD1 treatment to date of death from any cause (total estimated time to be 12 months)
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.
Start of anti-PD1 treatment to date of death from any cause (total estimated time to be 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Farrokh Dehdashti, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 31, 2026

Primary Completion (Estimated)

March 31, 2032

Study Completion (Estimated)

March 31, 2032

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202605001
  • R01CA311209 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data collected during the trial, metadata collection, and supporting files will be shared via the digital repository Digital Commons@Becker.

IPD Sharing Time Frame

Data will be available as soon as possible, but no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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