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

Overview

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.

Interventions

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

Primary outcome measures

• Perioperative success in imaging utilizing AURA10 PET-CT Specimen Imager [Time frame: Perioperative]

Secondary outcome measures (8)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

Belgium · 1 center

• University Hospital Ghent — Ghent

Publications

• 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

Identifiers

NCT: NCT05693363 · ONZ-2023-0105

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗