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| Name | Class |
|---|---|
| XEOS Medical | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-FDG AURA10 Specimen Imager | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AURA10 Specimen Imager | Device | High-resolution specimen imaging using the AURA10 PET-CT specimen imager during thoracic surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Perioperative success in imaging utilizing AURA10 PET-CT Specimen Imager | A measure of perioperative success in imaging 18F-FDG- uptake in resected specimens obtained during thoracic surgery utilizing a high-resolution PET-CT-scanner. | Perioperative |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected mediastinal or thoracic lymph nodes in terms of nodal staging. | Perioperative | |
| Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of bronchial margin assessment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liesbeth Desender, prof. dr. | Contact | +32 9 332 63 88 | liesbeth.desender@uzgent.be | |
| Lina Vermeir | Contact | +32 9 332 62 58 | studiestvhk@uzgent.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Recruiting | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32452298 | Background | 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. | |
| 31028165 |
| Label | URL |
|---|---|
| J. Ferlay, M. Ervik, F. Lam, M. Colombet, L. Mery, and M. Piñeros, "Global Cancer Observatory: Cancer Today. Lyon: International Agency for Research on Cancer." 2020 | View source |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Perioperative |
| Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of lung parenchyma margin assessment | 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. | Perioperative |
| Measure signal-to-noise ratio on post-processed PET-CT specimen images. | Perioperative |
| Comparison of lesion dimensions (e.g. delineation based on percentage of SUVmax, tumor-to-background ratios based on SUVpeak). | Perioperative |
| Occupational radiation exposure (µSv) to the staff in the operating room related to this study. | Perioperative |
| Correlation of high-resolution 18F-FDG-PET-CT images of lamellas of the resected specimen with histopathological whole-slide images. | Perioperative |
| 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. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |