5T4 Targeting Nanobody Probe for PET Imaging in Solid Tumors

Официальное название

Preparation of 5T4 Tumor Novel Target Nanobody PET Probe and Clinical Translation in Lung Cancer

Обзор

This study aims to evaluate a novel 5T4 targeted nanobody PET imaging tracer, 68Ga-MY, for the detection and evaluation of solid tumors. The 5T4 oncofoetal antigen is considered a valuable tumor-associated antigen, which is expressed in many different cancers, but is rarely expressed in normal adult tissues. And cell surface expression of 5T4 is an important property for antibody-targeted therapies. It has been shown that 5T4 is expressed on tumour-initiating cells (TICs) and associated with worse clinical outcome. Moreover, decreased adherence due to 5T4 expression may be associated with cancer spread. In this single-center, open-label, self-controlled study, approximately 20 patients with suspected or confirmed solid tumors will undergo PET/CT imaging using 68Ga-MY. The imaging results will be compared with 18F-FDG. The study will assess tracer uptake in tumor lesions and compare diagnostic performance between imaging methods. The results may help determine whether 68Ga-MY PET/CT can improve tumor detection, staging, and clinical evaluation in patients with solid tumors.

Вмешательства

• Препарат 18F-FDG
  All study participants will undergo one 18F-FDG PET/CT scan.
• Препарат 68Ga-MY
  68Ga-MY is an investigational tracer, and all participants will undergo 68Ga-MY scanning.

Первичные конечные точки

• Radiation Dosimetry of 68Ga-MY [Срок оценки: 1. From the start of drug administration to 14 days after injection 2.Dynamic PET/CT scanning from 0 to 40 minutes post-injection, followed by static scans at 1 hour, 2 hours, and 3 hours post-injection. 3.Prior to each patient injection.]
• Standardized Uptake Value (SUV) [Срок оценки: 1. From the start of drug administration to 14 days after injection 2.Dynamic PET/CT scanning from 0 to 40 minutes post-injection, followed by static scans at 1 hour, 2 hours, and 3 hours post-injection. 3.Prior to each patient injection.]
• The ratio of Tumor SUV to background SUV (SUVR) [Срок оценки: 1. From the start of drug administration to 14 days after injection 2.Dynamic PET/CT scanning from 0 to 40 minutes post-injection, followed by static scans at 1 hour, 2 hours, and 3 hours post-injection. 3.Prior to each patient injection]

Критерии участия

Критерии включения

• Patients with solid tumors;
• Presence of measurable lesions on imaging examinations;
• Expected survival ≥12 weeks.

Критерии исключения

• Severe hepatic or renal dysfunction;
• Women who are planning pregnancy, pregnant, or breastfeeding;
• Unable to remain in supine position for 30 minutes;
• Refusal to participate in this clinical study;
• Diagnosis of claustrophobia or other psychiatric disorders;
• Other conditions deemed by the investigator as inappropriate for participation in the trial.

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

Китай · 1 центр

• Beijing Cancer Hospital — Пекин

Идентификаторы

NCT: NCT07589101 · 2024YJZ64

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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