CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07659678
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2032
Completion
Mar 31, 2032

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Farrokh Dehdashti, MD
[email protected]
314-362-1474
Yongjian Liu, PhD (SUB_INVESTIGATOR)
Ryan Jackson, MD (SUB_INVESTIGATOR)
Sidharth Puram, MD, PhD (SUB_INVESTIGATOR)
Douglas Adkins, MD (SUB_INVESTIGATOR)
Ningying Wu, MD, PhD (SUB_INVESTIGATOR)
Chieh-Yu Lin, MD, PhD (SUB_INVESTIGATOR)
Richard Laforest, PhD (SUB_INVESTIGATOR)
Ying Hwey Nai, PhD (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Washington University School of Medicine· St Louis, MO

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