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Not yet recruiting NCT07659678

CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma

Phase II Interventional Head and Neck Squamous Cell Carcinoma Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma HNSCC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 64Cu-DOTA-ECL1i.
Who it may be relevant to
Registry 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. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • 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.

Primary outcome measures

  • Cohort 1 only: Semiquantitative 64Cu-DOTA-ECL1i PET/CT uptake [Time frame: 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)]
  • Cohort 2 only: Semiquantitative 64Cu-DOTA-ECL1i PET/CT uptake [Time frame: 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)]
  • Cohort 1 only: CCR2 expression in tumor tissue [Time frame: 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)]
  • 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)]
  • 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)]
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Identifiers

NCT: NCT07659678 · 202605001 · R01CA311209

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗