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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lung Neoplasms, PET-CT Specimen Imager

Intervention / Treatment
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* Device: AURA10 Specimen Imager


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-FDG AURA10 Specimen Imager<br>Intravenous injection of radiotracer (18F-FDG) (study-specific) Thoracic surgery (standard-of-care; not study-specific) High-resolution specimen imaging using the AURA10 PET-CT specimen imager (study-specific) Postoperative histopathological analysis of specimen (standard-of-care) | Device: AURA10 Specimen Imager<br>* High-resolution specimen imaging using the AURA10 PET-CT specimen imager during thoracic surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 |