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

Lung Neoplasms Clinical Trial

— ThorPET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05693363
• Other study ID #: ONZ-2023-0105
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2024
• Source: University Hospital, Ghent
• Contact: Liesbeth Desender, prof. dr.
• Phone: +32 9 332 63 88
• Email: liesbeth.desender[@]uzgent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	XEOS Medical

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

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

External Links

•   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