NCT05693363

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

1.6 years

First QC Date

January 11, 2023

Last Update Submit

January 13, 2025

Conditions

Lung NeoplasmsPET-CT Specimen Imager

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (1)

18F-FDG AURA10 Specimen Imager

EXPERIMENTAL

* 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

Interventions

AURA10 Specimen ImagerDEVICE

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

18F-FDG AURA10 Specimen Imager

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

RECRUITING

Related 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.

    PMID: 32452298BACKGROUND

  • 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.

    PMID: 31028165BACKGROUND

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Liesbeth Desender, prof. dr.

CONTACT

+32 9 332 63 88liesbeth.desender@uzgent.be

Lina Vermeir

CONTACT

+32 9 332 62 58studiestvhk@uzgent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 23, 2023

Study Start

January 1, 2024

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

January 15, 2025

Record last verified: 2025-01

Locations

BE(1)