18F-Pentixafor PET in Hematologic Malignancies

Официальное название

Prospective Clinical Study of 18F-Pentixafor PET Imaging in Hematologic Malignancies

Обзор

The aim of this study is to evaluate the efficacy of 18F-Pentixafor PET imaging in the diagnosis, staging and response evaluation of hematological malignancies.

Подробное описание

18F-FDG PET imaging based on the principle of glucose metabolism imaging is currently dominant in the staging and efficacy evaluation of lymphoma, but it is not suitable for a wider range of hematological tumors. Chemokine receptor 4 (CXCR-4) is a G protein-coupled receptor, which is overexpressed in a variety of hematological malignancies (MM, leukemia, lymphoma, etc.). It promotes tumor growth, invasion, metastasis, drug resistance, immune escape, and is associated with poor prognosis of tumors. 18Fluorine18 (18F)-NOTA-Pentixafor (18f-pentixafor) is a novel specific molecular probe targeting CXCR-4. Compared with 68Ga-Pentixafor, 18f-pentixafor has a longer half-life. More patients can be used in one synthesis, and the image quality is better and the spatial resolution is higher. Patients can undergo PET at 1 h after injection without special preparation. The aim of this study is to evaluate the performance of 18F-Pentixafor PET imaging in the diagnosis, staging, and response evaluation of hematological malignancies. Patients with suspected or histologically confirmed hematological malignancies will be enrolled in this study.

Вмешательства

• Препарат 18F-Pentixafor
  Patients with hematological malignancies receive 55 MBq/kg of 18F-Pentixafor intravenously followed by PET/CT or PET/MR after 60min of injection.

Первичные конечные точки

• Diagnostic efficacy [Срок оценки: through study completion, an average of 1.5 year]

Вторичные конечные точки (2)

• 18F-Pentixafor PET performence compared with 18F-FDG [Срок оценки: up to 24 months]
• Deauville Score [Срок оценки: through study completion, 3-4 years]

Критерии участия

Критерии включения

• Age of 18-80 years old, both sexes, with behavioral capacity;
• patients with suspected or confirmed hematological malignancies;
• 18F-FDG PET or other imaging examinations should be performed according to the treatment plan;
• For suspected patients, biopsy or needle biopsy is expected to obtain pathological results;
• Can provide informed consent, can understand and comply with the requirements of the study.

Критерии исключения

• pregnant and lactating women;
• patients with fear or radiophobia, or with mental disorder or primary affective disorder;
• received ionizing radiation outside the scope of this study for clinical medical or scientific research purposes within the past year, resulting in an annual radiation exposure dose exceeding 50 mSv;
• received investigational drugs or devices of uncertain efficacy or safety within 1 month;
• Any condition that the chairpersons of the study consider that any link related to the study may cause harm or have potential harm.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07122674 · FAHZU-CXCR4-Hemic

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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