Clinical trial · Interventional
Perioperative Specimen Imaging Using High-resolution 18F-FDG-PET-CT During Thoracic Surgery: a Pilot Study
NCT05693363CI-TRIAL-00084748ThorPETrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| PET-CT Specimen Imager | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AURA10 Specimen Imager | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-FDG AURA10 Specimen Imager
- 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)
- interventionNames
- Device: AURA10 Specimen Imager
Primary outcomes (1)
- measure
- Perioperative success in imaging utilizing AURA10 PET-CT Specimen Imager
- timeFrame
- Perioperative
- 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.
Secondary outcomes (8)
- measure
- Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected mediastinal or thoracic lymph nodes in terms of nodal staging.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDGoker 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 32452298
- BACKGROUNDPiron 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 31028165