Идёт набор NCT06715826

Target-specific immunoPET Imaging of Breast Cancer

Фаза I / Фаза II С лечением Breast Cancer Breast Neoplasms Breast Cancer Metastatic

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]F-RESCA-RT4, [18F]F-RESCA-RB14.
Кому может быть актуально: Состояния в реестре: Breast Cancer, Breast Neoplasms, Breast Cancer Metastatic. Базовые параметры: 18 лет — 75 лет · Женщины.
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 →

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Официальное название

Development and Clinical Translation of immunoPET Imaging Probes for Breast Cancer

Обзор

The aim of this study is to establish and optimize the Trop2/HER2-targeted PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in breast cancer will be evaluated.

Подробное описание

Enrolled patients will undergo whole-body\[18F\]F-RESCA-RT4(Trop2-targeted imaging probes ) or \[18F\]F-RESCA-RB14(HER2-targeted imaging probes) PET/CT scans at 1 hours after tracer injection(0.05-0.1 mCi/kg). Uptake of above imaging agents 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. The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. The exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers.

Вмешательства

Препарат [18F]F-RESCA-RT4
Enrolled patients will receive 0.05-0.1mCi/kg of \[18F\]F-RESCA-RT4. ImmunoPET/CT imaging will be acquired 1 hour after \[18F\]F-RESCA-RT4 injection.
Препарат [18F]F-RESCA-RB14
Enrolled patients will receive 0.05-0.1mCi/kg of \[18F\]F-RESCA-RB14. ImmunoPET/CT imaging will be acquired 1 hour after \[18F\]F-RESCA-RB14 injection.

Первичные конечные точки

Biodistribution of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14 [Срок оценки: 1 day from injection of the tracer]
Standardized uptake value (SUV) [Срок оценки: 1 day from injection of the tracer]
Radiation dosimetry of [18F]F-RESCA-RT4/[18F]F-RESCA-RB14 [Срок оценки: 1 day from injection of the tracer]
The correlation between Trop2 expression and [18F]F-RESCA-RT4 uptake value [Срок оценки: 60 days]
The correlation between HER2 expression and [18F]F-RESCA-RB14 uptake value [Срок оценки: 60 days]
Diagnostic value of Trop2/HER2-targeted immunPET in patients with breast cancer [Срок оценки: 30 days]

Вторичные конечные точки (2)

The predictive value of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14 in the course of targeted therapies [Срок оценки: 3-6 months]
Trop2/HER2-targeted immunPET in changing clinical decision-making for patients with breast cancer [Срок оценки: 3-6 months]

Критерии участия

Критерии включения

Aged 18-75 years old and of female gender；
Histologically confirmed diagnosis of breast cancer or suspected breast 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.