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Clinical Trial · NCT07659678
CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma
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).
Sponsor
Washington University School of Medicine
Phase
Phase 2
Contacts
Farrokh Dehdashti, MD (PRINCIPAL_INVESTIGATOR)
Farrokh Dehdashti, MD (CONTACT)
dehdashtif@wustl.edu
314-362-1474
ClinicalTrials.gov
NCT07659678Drug / Compound
ECL1i
Isotope(s):
COPPER-64
Radioisotope: Cu-64
Theranostic Role: PET Imaging
T1/2 (Half-Life): 12.7 Hours
Decay Mode: POSITRON β+, BETA, Electron Capture, GAMMA
Energy: 0.65 MeV, Gamma 511 keV
Range: max 2.5mm, mean 0.7mm
Decay Daughters: Ni64 (Stable), Zn64 (Stable)
Status: FDA Approval: DETECTNET®
Target(s):
- CCR2
Ligand Class: Peptides
Chelator: DOTA
Eligibility
Inclusion
- Lesion size of at least 1.0 cm in longest dimension by conventional imaging.
- 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
Exclusion
Exclusion criteria not yet provided.
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