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CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma

15 juin 2026 mis à jour par: Washington University School of Medicine
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).

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

90

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Missouri
      • St Louis, Missouri, États-Unis, 63110
        • Washington University School of Medicine
        • Contact:
        • Sous-enquêteur:
          • Ningying Wu, MD, PhD
        • Sous-enquêteur:
          • Douglas Adkins, MD
        • Sous-enquêteur:
          • Yongjian Liu, PhD
        • Sous-enquêteur:
          • Ryan Jackson, MD
        • Sous-enquêteur:
          • Sidharth Puram, MD, PhD
        • Sous-enquêteur:
          • Chieh-Yu Lin, MD, PhD
        • Sous-enquêteur:
          • Richard Laforest, PhD
        • Sous-enquêteur:
          • Ying Hwey Nai, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: 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.
Autres noms:
  • Copper Cu 64-DOTA-ECL1i
  • 64Cu-d(LGTFLKC)
  • Cu-64 DOTA-ECL1i
Expérimental: 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.
Médicament: 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.
Autres noms:
  • Copper Cu 64-DOTA-ECL1i
  • 64Cu-d(LGTFLKC)
  • Cu-64 DOTA-ECL1i

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Cohort 1 only: Semiquantitative 64Cu-DOTA-ECL1i PET/CT uptake
Délai: At baseline prior to scheduled surgery (estimated time frame: 1 day)
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
Délai: At time of surgery (total estimated time up to 14 days)
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
Délai: At baseline (estimated time frame: 1 day)
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
Délai: At time of surgery (total estimated time up to 14 days)
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
Délai: At time of surgery (total estimated time up to 14 days)
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
Délai: At baseline and post cycle 3 imaging (estimated time frame up to 9 weeks)
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
Délai: 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)
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)
Délai: Start of anti-PD1 treatment to date of disease progression or death from any cause (total estimated time to be 12 months)
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)
Délai: Start of anti-PD1 treatment to date of death from any cause (total estimated time to be 12 months)
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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Washington University School of Medicine

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Farrokh Dehdashti, MD, Washington University School of Medicine

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

31 août 2026

Achèvement primaire (Estimé)

31 mars 2032

Achèvement de l'étude (Estimé)

31 mars 2032

Dates d'inscription aux études

Première soumission

15 juin 2026

Première soumission répondant aux critères de contrôle qualité

15 juin 2026

Première publication (Réel)

22 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 202605001
  • R01CA311209 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

De-identified individual participant data collected during the trial, metadata collection, and supporting files will be shared via the digital repository Digital Commons@Becker.

Délai de partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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