Lung Neoplasms, PET-CT Specimen Imager
Conditions
Brief summary
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
DEVICEAURA10 Specimen Imager
High-resolution specimen imaging using the AURA10 PET-CT specimen imager during thoracic surgery.
Sponsors
XEOS Medical
University Hospital, Ghent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative success in imaging utilizing AURA10 PET-CT Specimen Imager | Perioperative | A measure of perioperative success in imaging 18F-FDG- uptake in resected specimens obtained during thoracic surgery utilizing a high-resolution PET-CT-scanner. |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of bronchial margin assessment. | 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 |
| Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected mediastinal or thoracic lymph nodes in terms of nodal staging. | 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 |
| Measure signal-to-noise ratio on post-processed PET-CT specimen images. | Perioperative |
Countries
Belgium
Contacts
Primary ContactLiesbeth Desender, prof. dr.
Backup ContactLina Vermeir
Outcome results
None listed