Идёт набор NCT06680089

CD70-targeted immunoPET Imaging of Kidney Cancer

Фаза II С лечением Urologic Neoplasms Urogenital Neoplasms Kidney Neoplasms Neoplasms

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: [18F]RCCB6.
Кому может быть актуально: Состояния в реестре: Urologic Neoplasms, Urogenital Neoplasms, Kidney Neoplasms, Neoplasms. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Study of the Clinical Application of [18F]RCCB6 PET/ CT Imaging in the Diagnosis of Kidney Cancer

Обзор

The aim of this study is to establish and optimize the \[18F\]RCCB6 PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agent in renal cancer (especially clear cell renal cell carcinoma) wil be evaluated.

Подробное описание

Histologically confirmed diagnosis of kidney cancer (especially clear cell renal cell carcinoma and papillary renal cell carcinoma) or suspected kidney cancer by diagnostic imaging will be included. Especially patients with suspected metastases or routine follow-up or surveillance or suitable for systemic treatments (e.g., combined immunotherapy and targeted therapies) will undergo \[18F\]RCCB6 immunoPET/CT scans. Enrolled patients will undergo whole-body \[18F\]RCCB6 immunoPET/CT scans at 1 hour after tracer injection(0.05-0.1 mCi/kg). Uptake of \[18F\]RCCB6 in tumor and normal organs/tissues will be scored visually and quantitatively. Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to evaluate the diagnostic efficacy. Furthermore, we will compare the diagnostic rates of \[18F\]RCCB6 immunoPET/CT with those of conventional imaging examinations, such as CT, MRI, and 18F-FDG PET/CT, etc.The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. Further explore the value of \[18F\]RCCB6 in treatment decision-making（staging, surveillance, and restaging） for kidney cancer.We will conduct an interim assessment when more than half of the patients have been enrolled.

Вмешательства

Препарат [18F]RCCB6
Enrolled patients will receive 0.05-0.1mCi/kg of \[18F\]RCCB6. ImmunoPET/CT imaging will be acquired 1 hour after \[18F\]RCCB6 injection.

Первичные конечные точки

Biodistribution of [18F]RCCB6 [Срок оценки: 1 day from injection of the tracer]
Standardized uptake value (SUV) [Срок оценки: 1 day from injection of the tracer]
The correlation between CD70 expression and [18F]RCCB6 uptake value [Срок оценки: 60 days]
Diagnostic value of [18F]RCCB6 PET in patients with ccRCC [Срок оценки: 30 days]
To explore the diagnostic performance of [18F]RCCB6 PET with that of conventional imaging and [18F]FDG PET [Срок оценки: 6 months]

Вторичные конечные точки (1)

[18F]RCCB6 PET/CT in changing clinical decision-making for ccRCC patients [Срок оценки: 3-6 months]

Критерии участия

Критерии включения

Aged 18-80 year-old and of either sex；
Histologically confirmed diagnosis of kidney cancer (especially clear cell renal cell carcinoma and papillary renal cell carcinoma) or suspected kidney cancer by diagnostic imaging;
Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.