Clinical trial NCT05693363: Perioperative Specimen Imaging Using High-resolution 18F-FDG-PET-CT During Thoracic Surgery: a Pilot Study
Official title: Perioperative Specimen Imaging Using High-resolution 18F-FDG-PET-CT During Thoracic Surgery: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Neoplasms
PET-CT Specimen Imager
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: XEOS Medical
First posted: 2023-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Perioperative success in imaging utilizing AURA10 PET-CT Specimen Imager
timeFrame: Perioperative
Secondary outcomes:
measure: Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected mediastinal or thoracic lymph nodes in terms of nodal staging.
timeFrame: Perioperative
measure: Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of bronchial margin assessment.
timeFrame: Perioperative
measure: Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of lung parenchyma margin assessment
timeFrame: Perioperative
measure: 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.
timeFrame: Perioperative
measure: Measure signal-to-noise ratio on post-processed PET-CT specimen images.
timeFrame: Perioperative
measure: Comparison of lesion dimensions (e.g. delineation based on percentage of SUVmax, tumor-to-background ratios based on SUVpeak).
timeFrame: Perioperative
measure: Occupational radiation exposure (µSv) to the staff in the operating room related to this study.
timeFrame: Perioperative
measure: Correlation of high-resolution 18F-FDG-PET-CT images of lamellas of the resected specimen with histopathological whole-slide images.
timeFrame: Perioperative
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
References:
citation: 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.
citation: 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.