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

Primary Purpose

Lung Neoplasms, PET-CT Specimen Imager

Status
Not yet recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
AURA10 Specimen Imager
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-FDG AURA10 Specimen Imager

Arm Description

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2023
Last Updated
September 5, 2023
Sponsor
University Hospital, Ghent
Collaborators
XEOS Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05693363
Brief Title
Perioperative Specimen Imaging Using High-resolution 18F-FDG-PET-CT During Thoracic Surgery: a Pilot Study
Acronym
ThorPET
Official Title
Perioperative Specimen Imaging Using High-resolution 18F-FDG-PET-CT During Thoracic Surgery: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
XEOS Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, PET-CT Specimen Imager

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-FDG AURA10 Specimen Imager
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
AURA10 Specimen Imager
Intervention Description
High-resolution specimen imaging using the AURA10 PET-CT specimen imager during thoracic surgery.
Primary Outcome Measure Information:
Title
Perioperative success in imaging utilizing AURA10 PET-CT Specimen Imager
Description
A measure of perioperative success in imaging 18F-FDG- uptake in resected specimens obtained during thoracic surgery utilizing a high-resolution PET-CT-scanner.
Time Frame
Perioperative
Secondary Outcome Measure Information:
Title
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
Title
Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of bronchial margin assessment.
Time Frame
Perioperative
Title
Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of lung parenchyma margin assessment
Time Frame
Perioperative
Title
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
Title
Measure signal-to-noise ratio on post-processed PET-CT specimen images.
Time Frame
Perioperative
Title
Comparison of lesion dimensions (e.g. delineation based on percentage of SUVmax, tumor-to-background ratios based on SUVpeak).
Time Frame
Perioperative
Title
Occupational radiation exposure (µSv) to the staff in the operating room related to this study.
Time Frame
Perioperative
Title
Correlation of high-resolution 18F-FDG-PET-CT images of lamellas of the resected specimen with histopathological whole-slide images.
Time Frame
Perioperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liesbeth Desender, prof. dr.
Phone
+32 9 332 63 88
Email
liesbeth.desender@uzgent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Lina Vermeir
Phone
+32 9 332 62 58
Email
studiestvhk@uzgent.be
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liesbeth Desender, prof. dr.
Email
liesbeth.desender@uzgent.be
First Name & Middle Initial & Last Name & Degree
Lina Vermeir
Phone
+32 9 332 62 58
Email
studiestvhk@uzgent.be
First Name & Middle Initial & Last Name & Degree
Liesbeth Desender, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Alexander Croo, Dr.
First Name & Middle Initial & Last Name & Degree
Frédéric De Ryck, Dr.
First Name & Middle Initial & Last Name & Degree
Annick D'Haeninck, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32452298
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.
Results Reference
background
PubMed Identifier
31028165
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.
Results Reference
background
Links:
URL
https://gco.iarc.fr/today
Description
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

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

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