Clinical Application Study of PET/CT for Differential Diagnosis of Non-small Cell Lung Cancer

Обзор

This study aims to explore the efficacy of Trop2, EpCAM-specific PET/CT imaging for noninvasive visualization of Trop2 or EpCAM expression levels in non-small cell lung cancer; and to explore the differences between novel target-specific PET/CT examinations and conventional 18F-FDG PET/CT in the diagnosis and differential diagnosis of solid lung nodules.

Подробное описание

A solid lung nodule was initially diagnosed as non-small cell lung cancer by chest CT. Patients with lung nodules subjected to 18F-FDG PET/CT with surgical resection/biopsy. Patients will also be included for routine follow-up, surveillance, and treatment efficacy evaluation.Enrolled patients will undergo whole-body immunoPET/CT scans 1-2 hours after tracer injection (0.05-0.1 mCi/kg). The uptake of imaging tracers in tumors 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 assess the diagnostic efficacy. The correlation between lesion uptake and Trop2 and EpCAM expression level determined by immunohistochemistry staining will be further analyzed. The primary exploration endpoint will be the tracers' imaging feasibility and preliminary diagnostic value compared to conventional imaging approaches like 18F-FDG PET/CT.

Вмешательства

• Препарат [68Ga]Ga-NOTA-T4
  Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-T4 injection.
• Препарат [68Ga]Ga-NOTA-RT4
  Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-RT4 injection.
• Препарат [18F]F-RESCA-T4
  Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-T4 injection.
• Препарат [18F]F-RESCA-RT4
  Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-RT4 injection.
• Препарат [18F]F-RESCA-EPCD6
  Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-EPCD6. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-EPCD6 injection.
• Препарат [68Ga]Ga-NOTA-EPCD6
  Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-EPCD6. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-EPCD6 injection.

Первичные конечные точки

• Biodistribution-Standardized uptake value (SUV) of normal tissues and organs. [Срок оценки: 1 day from injection of the tracers]
• SUV of tumors [Срок оценки: 1 day from injection of the tracers]
• Radiation dosimetry of tissues/organs [Срок оценки: 1 day from injection of the tracers]
• Radiation dosimetry of tumors [Срок оценки: 1 day from injection of the tracers]
• Radiation dosimetry of whole-body [Срок оценки: 1 day from injection of the tracers]
• Diagnostic sensitivity [Срок оценки: 30 days]
• Diagnostic specificity [Срок оценки: 30 days]
• Accuracy [Срок оценки: 30 days]
• Positive Predictive Value (PPV) [Срок оценки: 30 days]
• Negative Predictive Value (NPV) [Срок оценки: 30 days]

Вторичные конечные точки (5)

• ImmunoPET/CT in altering initial staging for patients with lung tumors [Срок оценки: 3-6 months]
• ImmunoPET/CT for postoperative surveillance for patients with lung tumors [Срок оценки: 3-6 months]
• ImmunoPET/CT for restaging for patients with lung tumors [Срок оценки: 3-6 months]
• ImmunoPET/CT in evaluating treatment responses [Срок оценки: 1-2years]
• ImmunoPET/CT in identifying inflammation and tumors in the lungs [Срок оценки: 1 day from injection of the tracers]

Критерии участия

Критерии включения

• Age 18-80 years;
• Imaging studies suspecting non-small cell lung cancer;
• Solid lung nodules (≥8 mm in diameter) diagnosed by chest ct, which are subject to 18F-FDG PET/CT and surgical resection/biopsy of lung nodules according to the NCCN guideline specifications for NSCLC in the 2024 edition;
• Patients or family members agreed to participate in this clinical study and signed an informed consent form.

Критерии исключения

• Women during pregnancy and lactation;
• Persons with a history of surgery and trauma that significantly affects metabolic distribution and anatomical structure;
• Persons with severe other systemic diseases or known hypersensitivity to humanized monoclonal antibody products;
• Patient is unable to cooperate in completing the PET/CT examination;
• Patient has participated in other clinical studies within the past year that have resulted in radiation exposures in excess of an effective dose of 50 mSv, in addition to the radiation exposures anticipated from participation in this clinical study;
• Patient should not participate in this clinical trial in the opinion of the investigator.

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

Диагностика

Центры проведения

Китай · 1 центр

• Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Шанхай

Идентификаторы

NCT: NCT07026110 · LY2024-329-C

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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