Perioperative Specimen Imaging Using High-resolution 18F-FDG-PET-CT During Thoracic Surgery: a Pilot Study

Обзор

In this pilot study the investigators propose the intraoperative use of a high-resolution PET-CT imaging system which can assess resection margins and lymph node status in the operating room. This will allow for a faster and stepwise assessment (estimated to be under 10 minutes per specimen), enabling the surgeon to decide on subsequent surgical steps after each previous assessment.

Вмешательства

• Устройство AURA10 Specimen Imager
  High-resolution specimen imaging using the AURA10 PET-CT specimen imager during thoracic surgery.

Первичные конечные точки

• Perioperative success in imaging utilizing AURA10 PET-CT Specimen Imager [Срок оценки: Perioperative]

Вторичные конечные точки (8)

• Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected mediastinal or thoracic lymph nodes in terms of nodal staging. [Срок оценки: Perioperative]
• Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of bronchial margin assessment. [Срок оценки: Perioperative]
• Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of lung parenchyma margin assessment [Срок оценки: Perioperative]
• Correlation between 18F-FDG uptake in the resected specimens and histopathological characteristics of the tumor, such as the type, grade, or stage of the tumor. [Срок оценки: Perioperative]
• Measure signal-to-noise ratio on post-processed PET-CT specimen images. [Срок оценки: Perioperative]
• Comparison of lesion dimensions (e.g. delineation based on percentage of SUVmax, tumor-to-background ratios based on SUVpeak). [Срок оценки: Perioperative]
• Occupational radiation exposure (µSv) to the staff in the operating room related to this study. [Срок оценки: Perioperative]
• Correlation of high-resolution 18F-FDG-PET-CT images of lamellas of the resected specimen with histopathological whole-slide images. [Срок оценки: Perioperative]

Критерии участия

Критерии включения

• Patient is 18 years of age or older.
• Patient with suspected or confirmed lung malignancies
• Patient is indicated to undergo thoracic surgery.
• Patient is estimated to be compliant for study participation by the investigator.
• Patient has freely given his/her informed consent to participate in this study.

Критерии исключения

• Patient has general or local contra-indications for thoracic surgery.
• Patient has active infection.
• Blood glucose level over 200 mg/dL on the day of surgery.
• Pregnancy or lactation.
• Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year

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

Бельгия · 1 центр

• University Hospital Ghent — Ghent

Публикации

• Goker M, Marcinkowski R, Van Bockstal M, Keereman V, Van Holen R, Van Dorpe J, Vandenberghe S, Brans B, Depypere H, Van den Broecke R. 18F-FDG micro-PET/CT for intra-operative margin assessment during breast-conserving surgery. Acta Chir Belg. 2020 Oct;120(5):366-374. doi: 10.1080/00015458.2020.1774163. Epub 2020 Jun 15. PMID 32452298
• Piron S, De Man K, Van Laeken N, D'Asseler Y, Bacher K, Kersemans K, Ost P, Decaestecker K, Deseyne P, Fonteyne V, Lumen N, Achten E, Brans B, De Vos F. Radiation Dosimetry and Biodistribution of 18F-PSMA-11 for PET Imaging of Prostate Cancer. J Nucl Med. 2019 Dec;60(12):1736-1742. doi: 10.2967/jnumed.118.225250. Epub 2019 Apr 26. PMID 31028165

Идентификаторы

NCT: NCT05693363 · ONZ-2023-0105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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