Идёт набор NCT06852638

CD70-targeted immunoPET Imaging of Malignant Cancers

Фаза II С лечением Renal Cancer Renal Clear Cell Carcinoma Lymphoma Lymphoma, Large B-Cell, Diffuse

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-RCCB6, [18F]F-RESCA-R8B4, [68Ga]Ga-NOTA-R8B4, [18F]F-RESCA-RD06.
Кому может быть актуально: Состояния в реестре: Renal Cancer, Renal Clear Cell Carcinoma, Lymphoma, Lymphoma, Large B-Cell, Diffuse. 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 →

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Официальное название

CD70-targeted PET/ CT in the Diagnosis of Malignant Cancers

Обзор

This study aims to determine the value of cluster of differentiation (CD70)-targeted immuno-positron emission tomography/computed tomography (immunoPET/CT) imaging for diagnosing human malignancies, including renal cell carcinoma (particularly clear cell renal cell carcinoma), lymphoma, and nasopharyngeal carcinoma (NPC), among others.

Подробное описание

Histologically confirmed malignant cancers (renal cancer (especially clear cell renal cell carcinoma), lymphoma, or nasopharyngeal carcinoma (NPC)) or patients with suspected malignant cancers (renal cancer (especially clear cell renal cell carcinoma), lymphoma, or nasopharyngeal carcinoma (NPC)) indicated by conventional diagnostic imaging will be included. Patients will also be included for routine follow-up, surveillance, and evaluation of treatment efficacy following the initial CD70-targeted immunoPET/CT imaging.

Enrolled patients will undergo whole-body immunoPET/CT scans 1-2 hours after tracer injection (0.01-0.1 mCi/kg). Uptake of imaging tracers in tumors and normal organs/tissues will be scored both visually and quantitatively.

Tumor uptake will be quantified using the maximum standard uptake value (SUVmax). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to assess diagnostic efficacy. The correlation between lesion uptake and CD70 expression levels, as determined by immunohistochemical staining, will be further analyzed. The primary exploratory endpoint will be the imaging feasibility of the tracers and their preliminary diagnostic value compared with conventional imaging approaches such as 18F-FDG PET/CT, CT/MRI. The secondary endpoint is the impact of CD70-targeted immunoPET/CT imaging on clinical decision-making.

Вмешательства

Препарат [18F]F-RESCA-RCCB6
Enrolled patients will receive 0.01-0.1 mCi/kg of \[18F\]RCCB6. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]RCCB6 injection.
Препарат [18F]F-RESCA-R8B4
Enrolled patients will receive 0.01-0.1 mCi/kg of \[18F\]R8B4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]R8B4 injection.
Препарат [68Ga]Ga-NOTA-R8B4
Enrolled patients will receive 0.01-0.1 mCi/kg of \[68Ga\]R8B4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]R8B4 injection.
Препарат [18F]F-RESCA-RD06
Enrolled patients will receive 0.01-0.1 mCi/kg of \[18F\]F-RESCA-RD06. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-RD06 injection.
Препарат [68Ga]Ga-NOTA-RD06
Enrolled patients will receive 0.01-0.1 mCi/kg of \[68Ga\]Ga-NOTA-RD06. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-RD06 injection.

Первичные конечные точки

The uptake patterns of CD70-targeted tracers across different tumors [Срок оценки: One month after the injection of the tracers]
The diagnostic value of CD70-targeted immunoPET/CT across different tumors [Срок оценки: One month from the injection of the tracers]

Вторичные конечные точки (1)

The impact of CD70-targeted immunoPET/CT on clinical decision-making [Срок оценки: 3-6 months after the injection of the tracers]

Критерии участия

Критерии включения

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