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NCT Number: NCT07659678

CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma

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).

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Disease Attributes Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma HNSCC Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location contact

Chieh-Yu Lin, MD, PhD

SUB_INVESTIGATOR

Douglas Adkins, MD

SUB_INVESTIGATOR

Farrokh Dehdashti, MD

CONTACT

[email protected]

314-362-1474

Ningying Wu, MD, PhD

SUB_INVESTIGATOR

Richard Laforest, PhD

SUB_INVESTIGATOR

Ryan Jackson, MD

SUB_INVESTIGATOR

Sidharth Puram, MD, PhD

SUB_INVESTIGATOR

Ying Hwey Nai, PhD

SUB_INVESTIGATOR

Yongjian Liu, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

64Cu-DOTA-ECL1i

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Farrokh Dehdashti, MD

CONTACT

[email protected]

314-362-1474

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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