CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma

NCT07659678 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 202605001R01CA311209
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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).

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

Keywords

Head and neck cancer; P16+ and P16-; PET; CCR2

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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

  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.

  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.

  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.

  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.

  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.

  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.

  Start of anti-PD1 treatment to date of death from any cause (total estimated time to be 12 months)

Study Arms (2)

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.

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.

Drug: 64Cu-DOTA-ECL1i

Interventions

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.

Also known as: Copper Cu 64-DOTA-ECL1i, 64Cu-d(LGTFLKC), Cu-64 DOTA-ECL1i

Cohort 1: Newly Diagnosed HNSCC who are scheduled to undergo surgical resection; Cohort 2: Recurrent/metastatic HNSCC who are candidates for first-line anti-PD1 therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Recurrence; Neoplasm Metastasis; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Study Officials

• Farrokh Dehdashti, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farrokh Dehdashti, MD

CONTACT

314-362-1474; dehdashtif@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): March 31, 2032
• Study Completion (Estimated): March 31, 2032
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

US (1)