First-in-human Study of Interferon-y PET Imaging to Assess Response to Immunotherapy

Официальное название

IFN-y PET Imaging: Bench to Bedside

Обзор

The goal of this clinical trial is to investigate the use of \[89Zr\]Zr-DFO-emapalumab as an IFN-γ PET imaging agent to detect lesions and response to therapy among treatment-naïve non-small cell lung cancer (NSCLC) patients. PET scans following the imaging agent will be completed prior to and about 30 days after starting immunotherapy.

Подробное описание

Participants will be enrolled into the clinical trial once confirmed eligible. Screening activities include, standard of care blood work, medical history and a physical exam.

-Within 14 days of starting immunotherapy, participants will complete PET scans 1-2 hours post-tracer administration, again on the day following tracer administration, and 3-5 days after the tracer administration. This sequence may be repeated 25-45 days after the start of treatment with immunotherapy for a total of two tracer injections and up to six PET scans.

Вмешательства

• Препарат [89Zr]Zr-DFO-emapalumab
  Radiotracer \[89Zr\]Zr-DFO-emapalumab administration followed by 3 PET Scans (day 0, day 1 and day 3-5) within 14 days of starting immunotherapy and repeated once 25-45 days after immunotherapy started

Первичные конечные точки

• peak Standard Uptake Value (SUVpeak) [Срок оценки: Up to Day 45]
• mean Standard Uptake Value (SUVmean) [Срок оценки: Up to Day 45]
• maximum Standard Uptake Value (SUVmax) [Срок оценки: Up to Day 45]

Вторичные конечные точки (3)

• change of SUVpeak [Срок оценки: Up to Day 45]
• change of SUVmean [Срок оценки: Up to Day 45]
• change of SUVmax [Срок оценки: Up to Day 45]

Критерии участия

Inclusion

• Prior histologic or cytologic diagnosis of non-small cell lung cancer.
• FDG PET done within 2 months of the baseline imaging, as part of standard-of-care.
• measurable disease by RECIST 1.1 with at least one lesion of at least 2 cm in a region of the body that can be imaged by PET (e.g.,outside of the liver)
• must be able to lie still for the tests. Their girth and weight must be suitable to enter the gantry, which varies per tomograph.
• must be >18 years old.
• Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the cancer center.
• Physical exam, CBC and Multiphasic (including electrolytes, BUN, creatinine, total bilirubin, AST, and ALT) must be done within 28 days prior to PET imaging

Exclusion

• No prior immunotherapy for current stage of NSCLC (Non Small Cell Lung Cancer). Immunotherapy in neoadjuvant or adjuvant setting and have recurrence at least 12 months following completion of immunotherapy are eligible after discussion with the principle investigator.
• Pregnant or breast feeding individuals.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Karmanos Cancer Institute — Detroit

Идентификаторы

NCT: NCT06439914 · 2023-092

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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