CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma

Обзор

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).

Вмешательства

• Препарат 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.

Первичные конечные точки

• Cohort 1 only: Semiquantitative 64Cu-DOTA-ECL1i PET/CT uptake [Срок оценки: At baseline prior to scheduled surgery (estimated time frame: 1 day)]
• Cohort 1 only: Quantitative 64Cu-DOTA-ECL1i PET/CT uptake [Срок оценки: At time of surgery (total estimated time up to 14 days)]
• Cohort 2 only: Semiquantitative 64Cu-DOTA-ECL1i PET/CT uptake [Срок оценки: At baseline (estimated time frame: 1 day)]
• Cohort 2 only: Quantitative 64Cu-DOTA-ECL1i PET/CT uptake [Срок оценки: At time of surgery (total estimated time up to 14 days)]
• Cohort 1 only: CCR2 expression in tumor tissue [Срок оценки: 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 [Срок оценки: At baseline and post cycle 3 imaging (estimated time frame up to 9 weeks)]
• Cohort 2 only: Objective response [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Start of anti-PD1 treatment to date of death from any cause (total estimated time to be 12 months)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT07659678 · 202605001 · R01CA311209

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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