Recruiting
Phase 2

Cu-64 DOTA-ECL1i

Sponsor:

Washington University School of Medicine

Code:

NCT07659678

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

64Cu-DOTA-ECL1i

Study Details

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

Study ID

NCT07659678

Start date

Oct 31, 2026

Status verified date

Jun, 2026

Completion date

May 31, 2032

Anticipated

Primary completion date

May 31, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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 measure

  • 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) ]

Central Contacts and Locations

Central contacts

Farrokh Dehdashti, MD

314-362-1474dehdashtif@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Farrokh Dehdashti, MD

314-362-1474dehdashtif@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Oct 7, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.