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NCT Number: NCT05693363

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

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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Key information

Conditions

Lung Neoplasms Lung Diseases Neoplasms Neoplasms by Site PET-CT Specimen Imager Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AURA10 Specimen Imager

Device

High-resolution specimen imaging using the AURA10 PET-CT specimen imager during thoracic surgery.

Primary outcomes

  1. Perioperative success in imaging utilizing AURA10 PET-CT Specimen Imager

    Time frame: 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 outcomes

  1. Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected mediastinal or thoracic lymph nodes in terms of nodal staging.

    Time frame: Perioperative

  2. Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of bronchial margin assessment.

    Time frame: Perioperative

  3. Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of lung parenchyma margin assessment

    Time frame: Perioperative

  4. 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.

    Time frame: Perioperative

  5. Measure signal-to-noise ratio on post-processed PET-CT specimen images.

    Time frame: Perioperative

  6. Comparison of lesion dimensions (e.g. delineation based on percentage of SUVmax, tumor-to-background ratios based on SUVpeak).

    Time frame: Perioperative

  7. Occupational radiation exposure (µSv) to the staff in the operating room related to this study.

    Time frame: Perioperative

  8. Correlation of high-resolution 18F-FDG-PET-CT images of lamellas of the resected specimen with histopathological whole-slide images.

    Time frame: Perioperative

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • XEOS Medical

Registry information

Acronym: ThorPET

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2023
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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