PET/MR in the Staging and Efficacy Evaluation of Newly Diagnosed NK/T-cell Lymphoma

Официальное название

PET/MR in the Staging and Efficacy Evaluation of Newly Diagnosed NK/T-cell Lymphoma: a Prospective, Single-arm Clinical Study

Обзор

This study intends to evaluate the application value of Positron Emission Tomography/Magnetic Resonance (PET/MR) in the staging and efficacy evaluation of NK/T cell lymphoma, aiming to explore a more accurate system for predicting the prognosis of patients and guiding the treatment.

Подробное описание

Nature Killer/T-cell Lymphoma (NKTCL) is a highly heterogeneous, aggressive lymphoma subtype with poor prognosis. Ninty percent of patients have lesions involving the nasal region, other extranodal organs include adrenal glands, gastrointestinal tract, skin and so on. Local tumor infiltration (bone, skin, paranasal sinus, etc) is a poor prognostic factor. Therefore, NK/T-cell lymphomas have high demands on the resolution of fine anatomical structures. PET/CT and nasopharyngeal contrast-enhanced MR are routine examination methods for diagnostic staging and efficacy evaluation, but the images cannot be fused, and the divided examinations bring inconvenience to patients.

Вмешательства

• Устройство Positron Emission Tomography/Magnetic Resonance (PET/MR)
  18F-FDG PET/MR imaging (manufacturer: Siemens, model: Biography mMR). Research devices are marketed products.

Первичные конечные точки

• The sensitivity, specificity and accuracy of PET/MR in the staging of newly diagnosed NK/T-cell lymphoma patients [Срок оценки: Baseline]
• The sensitivity, specificity and accuracy of PET/MR in the efficacy evaluation of newly diagnosed NK/T-cell lymphoma patients [Срок оценки: After at least 2 cycles]

Вторичные конечные точки (1)

• Exploratory construction of prognostic prediction or efficacy evaluation system for newly treated NK/T-cell lymphoma based on PET/MR imaging indicators. [Срок оценки: Baseline up to data cut-off (up to approximately 4 years)]

Критерии участия

Критерии включения

• Pathologically diagnosed NK/T-cell lymphoma based on the WHO classification 2016
• Age from 14 to 70 years-old
• ECOG 0-2 score
• Patients with a life expectancy of at least 6 months
• Patient has not been treated before for NK/T cell lymphoma
• Commit to abide by the research procedures and cooperate with the implementation of the whole process of research
• Written informed consent

Критерии исключения

\- Subjects who meet any of the following criteria are not eligible for study entry

• Diagnosed aggressive NK cell leukemia
• Pregnant or lactating women
• Liver and kidney insufficiency
• Other PET/MR contraindications:

• Those with implanted functional electronic devices such as cardiac pacemakers
• Carotid aneurysm clipping and other implants are ferromagnetic materials
• Implanted perfusion devices such as insulin perfusion pumps
• Those who do not cooperate in examinations such as coma, mental illness, and critically ill patients
• Those who are claustrophobic
• Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study

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

Другое

Центры проведения

Китай · 1 центр

• Ruijin Hospital — Шанхай

Идентификаторы

NCT: NCT05662540 · NK-PETMR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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