Lung NeoplasmsThorPETNCT05693363
Perioperative Specimen Imaging Using High-resolution 18F-FDG-PET-CT During Thoracic Surgery: a Pilot Study
A study testing AURA10 Specimen Imager in people with Lung Neoplasms and PET-CT Specimen Imager, run by University Hospital, Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, PET-CT Specimen Imager
- What is being tested?
- AURA10 Specimen Imager
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Ghent
Ghent, 9000
Liesbeth Desender, prof. dr., liesbeth.desender@uzgent.be
Lina Vermeir, +32 9 332 62 58, studiestvhk@uzgent.be
About this 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.
- Conditions
- Lung Neoplasms, PET-CT Specimen Imager
- Being tested
- AURA10 Specimen Imager
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AURA10 Specimen ImagerDevice
High-resolution specimen imaging using the AURA10 PET-CT specimen imager during thoracic surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: AURA10 Specimen Imager |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Perioperative
Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of bronchial margin assessment.
Measured: Perioperative
Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of lung parenchyma margin assessment
Measured: 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.
Measured: Perioperative
Measure signal-to-noise ratio on post-processed PET-CT specimen images.
Measured: Perioperative
Comparison of lesion dimensions (e.g. delineation based on percentage of SUVmax, tumor-to-background ratios based on SUVpeak).
Measured: Perioperative
Occupational radiation exposure (µSv) to the staff in the operating room related to this study.
Measured: Perioperative
Correlation of high-resolution 18F-FDG-PET-CT images of lamellas of the resected specimen with histopathological whole-slide images.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Jan 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- XEOS Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693363
- Sponsor's protocol ID
- ONZ-2023-0105
- Acronym
- ThorPET
- Status last verified
- Jan 2025
- First submitted
- 11 Jan 2023
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32452298Piron 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.
PubMed 31028165
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Specimen Imaging Using High-resolution 18F-FDG-PET-CT During Thoracic Surgery: a Pilot Study
- ClinicalTrials.gov ID
- NCT05693363
- Acronym / sponsor ID
- ThorPET / ONZ-2023-0105
- Conditions
- Lung Neoplasms, PET-CT Specimen Imager
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- XEOS Medical
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FDG AURA10 Specimen Imager | Experimental | Device: AURA10 Specimen Imager* 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AURA10 Specimen ImagerHigh-resolution specimen imaging using the AURA10 PET-CT specimen imager during thoracic surgery. | Device | 18F-FDG AURA10 Specimen Imager |
Primary outcome
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.
8 secondary outcomes
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
Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of bronchial margin assessment.
Time frame: Perioperative
Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of lung parenchyma margin assessment
Time frame: 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.
Time frame: Perioperative
Measure signal-to-noise ratio on post-processed PET-CT specimen images.
Time frame: Perioperative
Comparison of lesion dimensions (e.g. delineation based on percentage of SUVmax, tumor-to-background ratios based on SUVpeak).
Time frame: Perioperative
Occupational radiation exposure (µSv) to the staff in the operating room related to this study.
Time frame: Perioperative
Correlation of high-resolution 18F-FDG-PET-CT images of lamellas of the resected specimen with histopathological whole-slide images.
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Background: PubMed 32452298Goker 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.
- Background: PubMed 31028165Piron 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.
- 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." 2020Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AURA10 Specimen Imager in people with Lung Neoplasms and PET-CT Specimen Imager, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liesbeth Desender, prof. dr. (+32 9 332 63 88, liesbeth.desender@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative success in imaging utilizing AURA10 PET-CT Specimen Imager (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05693363, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.