Fluorodeoxyglucose F18IMA-PANC-CANCT05023291
Peroperative Assessment of Tumour Resection Margins Using High-resolution 18F-FDG-PET/CT in Pancreatic Adenocarcinoma
A study testing Positron Emissie Tomografie - Computer Tomografie in people with Fluorodeoxyglucose F18, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
One of the main risks for recurrence in patients with pancreatic cancer is incomplete surgery of the primary tumor. During the operation, the surgeon bases himself for this on imaging and peroperative vision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluorodeoxyglucose F18
- What is being tested?
- Positron Emissie Tomografie - Computer Tomografie
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Mar 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult patients (≥ 18 years)
- Signed informed consent
- Patient with a Pancreas Ca who is undergoing Whipple surgery
- Patient with ASA grade 1 to 3
Who cannot join
- Patient has ASA 4
- Patient under long-term use of anticoagulant therapy (except low dose aspirin)
- Patient has tumor invasion of blood vessels
- The patient undergoes a total pancreatectomy
- Patient undergoes a double derivation
- pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peroperative Assessment of Tumour Resection Margins Using High-resolution 18F-FDG-PET/CT in Pancreatic Adenocarcinoma, a Pilot Study: IMA PancreasCA (BC-05923)
One of the main risks for recurrence in patients with pancreatic cancer is incomplete surgery of the primary tumor. During the operation, the surgeon bases himself for this on imaging and peroperative vision. Unfortunately, this is not always sufficient and it is sometimes determined after surgery that the cutting edges are not free of tumor cells. Research has already shown that there is a significantly better survival when a margin of at least 1 mm is maintained between the macroscopic tumor and the cut surface. It is therefore important to remove the tumor as completely as possible without the risk of residual tissue and with a sufficiently wide margin.
The only method that can currently be used to determine during surgery if the tumor has been completely removed is to use "frozen sections". With a frozen section, the surgical piece is sent to the pathology department during the operation, where sections are taken from the edges. These are frozen in nitrogen and immediately viewed by a pathologist. If the cut edge is positive, this will be passed on to the surgeon who will take a wider resection if possible. Unfortunately, this method is time consuming and labor intensive. The evaluation of these cut edges on frozen section is not easy and requires a lot of experience. The percentage of false negative reviews for frozen section is not high, but it is true that it is not non-existent either. In addition, it is not possible to evaluate all cleavage surfaces peroperatively. This is currently happening for the distal pancreatic cutting edge and the bile duct cutting edge, but not, for example, for the posterior pancreatic surface and for the surface of the groove in which the superior mesenteric vein runs.
The use of peroperative imaging in the form of 18F-FDG PET-CT scan of the tumor would be a clear asset for this. This would not only be faster than frozen sections, but also provide a full 3-dimensional image of the extracted specimen, which may provide more insights than 2D frozen sections. The ultimate goal of this study is to bring the high resolution PET-CT system into the operating theater. For example, during the operation, in the operating theater itself, it could be determined where residual tumor tissue would be present and then performed a wider resection in order to avoid a positive margin status.
Read the detailed description
This study will be conducted in patients undergoing surgery for pancreatic cancer removal. The aim of this study is to see whether all tumor tissue has been removed in this patient group during the removal of the tumor. This will be done with the help of a high resolution PET-CT (Positron Emission Tomography - Computer Tomography) system, developed by the Faculty of Engineering, UGent, and commercialized by Xeos (spin-off from Ghent University). This system is the compact (and transportable version) of the standard PET-CT and was initially developed for imaging small laboratory animals, typically mice, for which a particularly high resolution is required. In this study, the high-resolution PET-CT system will be used to evaluate the cutting edges after tumor resection. The goal is to evaluate the distance of the tumor cells from the cutting edges of the surgical piece.
The patient receives an intravenous injection of radiolabeled sugar (18F-FDG). 18F-FDG is the standard PET tracer for diagnostic PET-CT research. This standard dose will always be calculated according to the formula: 3.7 x body weight + 37 Mbq. The injection will be carried out by a trained "helper" under article 53.2 of the Royal Decree of 30/08/2001. This injection is always carried out under the responsibility of Dr. Kathia De Man or Dr. Bliede Van den Broeck as a recognized and licensed nuclear medicine doctor. The location of the injection will depend on the logistical possibilities of the day of operation. Due to the radioactive decay of the molecule, the optimal moment of injection of this radiolabeled sugar is best as short as possible before scanning the tumor. If possible, a "helper" will transport the radiolabelled sugar to the operating theater (OR) and the injection will be performed in the OR itself. If this option does not exist, the injection will be performed at the nuclear medicine department of UZ Gent, after which the injected patient will be immediately taken to the OR. Based on the natural decay of the radioactivity, the results of both injection times can be compared using the time of injection, injected dose and time of scan. The data collected during the study will allow to calculate post-hoc what the ideal dose of 18F-FDG is for this indication, i.e. the lowest possible dose for the patient, which can still be optimally measured by the scanner . The ALARA (as low as reasonably achievable) principle always applies.
The surgery to remove the pancreatic tumor follows the standard procedure. After removal, the surgical piece is first taken to the anatomopathology department. Frozen sections will be taken and analyzed directly for intake by tumor cells. Immediate feedback on this is given to the surgeon in the OR, as is done within the standard procedure. After taking the frozen sections, the rest of the specimen is taken to the "INFINITY" lab on the UZ Gent campus. Here a high-resolution PET-CT scan is performed on the surgical piece. After the PET-CT scan, the surgical piece is returned to the pathological anatomy department for further standard pathological evaluation. No information about the PET-CT results will be given to the surgeon during surgery so as not to interfere with the standard surgical procedure. The results of the high resolution PET-CT scan will be correlated post-hoc with the routine histopathological results of the tumor specimen, which is considered the gold standard.
- Conditions
- Fluorodeoxyglucose F18
- Being tested
- Positron Emissie Tomografie - Computer Tomografie
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron Emissie Tomografie - Computer TomografieDiagnostic test
In this study, the high-resolution PET-CT system will be used to evaluate the cutting edges after tumor resection. The goal is to evaluate the distance of the tumor cells from the cutting edges of the surgical piece. The patient receives an intravenous injection of radiolabeled sugar (18F-FDG). 18F-FDG is the standard PET tracer for diagnostic PET-CT research. This standard dose will always be calculated according to the formula: 3.7 x body weight + 37 Mbq.
| Study group | Role | What they receive |
|---|---|---|
| test group | Other | All patients who give their consent for this study will participate in the test group and will therefore receive the injection with 18F-FDG and images (PET / CT) will be made of the resection piece. Receives: Diagnostic Test: Positron Emissie Tomografie - Computer Tomografie |
What is being measured
The primary outcome is the main question the study is designed to answer.
marge assessment immediately after resection
first PET imaging after resection for visiuallazation of the proximity of the leasion then frozen section of the cutting edge to astablising the same result and comparing the results from PET and frozen section.
Measured: marge assessment immediately performed results known after 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start30 Mar 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: no effective result after first 5 patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluorodeoxyglucose F18Studies 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederik Berrevoet, MD-PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023291
- Sponsor's protocol ID
- BC-05923
- Acronym
- IMA-PANC-CA
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2020
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peroperative Assessment of Tumour Resection Margins Using High-resolution 18F-FDG-PET/CT in Pancreatic Adenocarcinoma, a Pilot Study: IMA PancreasCA (BC-05923)
- ClinicalTrials.gov ID
- NCT05023291
- Acronym / sponsor ID
- IMA-PANC-CA / BC-05923
- Conditions
- Fluorodeoxyglucose F18
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no effective result after first 5 patients
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Aug 2021 (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.
One of the main risks for recurrence in patients with pancreatic cancer is incomplete surgery of the primary tumor. During the operation, the surgeon bases himself for this on imaging and peroperative vision. Unfortunately, this is not always sufficient and it is sometimes determined after surgery that the cutting edges are not free of tumor cells. Research has already shown that there is a significantly better survival when a margin of at least 1 mm is maintained between the macroscopic tumor and the cut surface. It is therefore important to remove the tumor as completely as possible without the risk of residual tissue and with a sufficiently wide margin.
The only method that can currently be used to determine during surgery if the tumor has been completely removed is to use "frozen sections". With a frozen section, the surgical piece is sent to the pathology department during the operation, where sections are taken from the edges. These are frozen in nitrogen and immediately viewed by a pathologist. If the cut edge is positive, this will be passed on to the surgeon who will take a wider resection if possible. Unfortunately, this method is time consuming and labor intensive. The evaluation of these cut edges on frozen section is not easy and requires a lot of experience. The percentage of false negative reviews for frozen section is not high, but it is true that it is not non-existent either. In addition, it is not possible to evaluate all cleavage surfaces peroperatively. This is currently happening for the distal pancreatic cutting edge and the bile duct cutting edge, but not, for example, for the posterior pancreatic surface and for the surface of the groove in which the superior mesenteric vein runs.
The use of peroperative imaging in the form of 18F-FDG PET-CT scan of the tumor would be a clear asset for this. This would not only be faster than frozen sections, but also provide a full 3-dimensional image of the extracted specimen, which may provide more insights than 2D frozen sections. The ultimate goal of this study is to bring the high resolution PET-CT system into the operating theater. For example, during the operation, in the operating theater itself, it could be determined where residual tumor tissue would be present and then performed a wider resection in order to avoid a positive margin status.
Detailed description
This study will be conducted in patients undergoing surgery for pancreatic cancer removal. The aim of this study is to see whether all tumor tissue has been removed in this patient group during the removal of the tumor. This will be done with the help of a high resolution PET-CT (Positron Emission Tomography - Computer Tomography) system, developed by the Faculty of Engineering, UGent, and commercialized by Xeos (spin-off from Ghent University). This system is the compact (and transportable version) of the standard PET-CT and was initially developed for imaging small laboratory animals, typically mice, for which a particularly high resolution is required. In this study, the high-resolution PET-CT system will be used to evaluate the cutting edges after tumor resection. The goal is to evaluate the distance of the tumor cells from the cutting edges of the surgical piece.
The patient receives an intravenous injection of radiolabeled sugar (18F-FDG). 18F-FDG is the standard PET tracer for diagnostic PET-CT research. This standard dose will always be calculated according to the formula: 3.7 x body weight + 37 Mbq. The injection will be carried out by a trained "helper" under article 53.2 of the Royal Decree of 30/08/2001. This injection is always carried out under the responsibility of Dr. Kathia De Man or Dr. Bliede Van den Broeck as a recognized and licensed nuclear medicine doctor. The location of the injection will depend on the logistical possibilities of the day of operation. Due to the radioactive decay of the molecule, the optimal moment of injection of this radiolabeled sugar is best as short as possible before scanning the tumor. If possible, a "helper" will transport the radiolabelled sugar to the operating theater (OR) and the injection will be performed in the OR itself. If this option does not exist, the injection will be performed at the nuclear medicine department of UZ Gent, after which the injected patient will be immediately taken to the OR. Based on the natural decay of the radioactivity, the results of both injection times can be compared using the time of injection, injected dose and time of scan. The data collected during the study will allow to calculate post-hoc what the ideal dose of 18F-FDG is for this indication, i.e. the lowest possible dose for the patient, which can still be optimally measured by the scanner . The ALARA (as low as reasonably achievable) principle always applies.
The surgery to remove the pancreatic tumor follows the standard procedure. After removal, the surgical piece is first taken to the anatomopathology department. Frozen sections will be taken and analyzed directly for intake by tumor cells. Immediate feedback on this is given to the surgeon in the OR, as is done within the standard procedure. After taking the frozen sections, the rest of the specimen is taken to the "INFINITY" lab on the UZ Gent campus. Here a high-resolution PET-CT scan is performed on the surgical piece. After the PET-CT scan, the surgical piece is returned to the pathological anatomy department for further standard pathological evaluation. No information about the PET-CT results will be given to the surgeon during surgery so as not to interfere with the standard surgical procedure. The results of the high resolution PET-CT scan will be correlated post-hoc with the routine histopathological results of the tumor specimen, which is considered the gold standard.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| test group | Other | Diagnostic Test: Positron Emissie Tomografie - Computer TomografieAll patients who give their consent for this study will participate in the test group and will therefore receive the injection with 18F-FDG and images (PET / CT) will be made of the resection piece. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (≥ 18 years)
- Signed informed consent
- Patient with a Pancreas Ca who is undergoing Whipple surgery
- Patient with ASA grade 1 to 3
Key exclusion criteria (6 listed)
- Patient has ASA 4
- Patient under long-term use of anticoagulant therapy (except low dose aspirin)
- Patient has tumor invasion of blood vessels
- The patient undergoes a total pancreatectomy
- Patient undergoes a double derivation
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 |
|---|---|---|
| Positron Emissie Tomografie - Computer TomografieIn this study, the high-resolution PET-CT system will be used to evaluate the cutting edges after tumor resection. The goal is to evaluate the distance of the tumor cells from the cutting edges of the surgical piece. The patient receives an intravenous injection of radiolabeled sugar (18F-FDG). 18F-FDG is the standard PET tracer for diagnostic PET-CT research. This standard dose will always be calculated according to the formula: 3.7 x body weight + 37 Mbq. | Diagnostic test | test group |
Primary outcome
marge assessment immediately after resection
Time frame: marge assessment immediately performed results known after 3 weeks
first PET imaging after resection for visiuallazation of the proximity of the leasion then frozen section of the cutting edge to astablising the same result and comparing the results from PET and frozen section.
Results and safety
The study was stopped early (reason given: no effective result after first 5 patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Frederik Berrevoet, MD-PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positron Emissie Tomografie - Computer Tomografie in people with Fluorodeoxyglucose F18, 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 5 Sep 2023. 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?
The study was stopped early (reason given: no effective result after first 5 patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
marge assessment immediately after resection (time frame: marge assessment immediately performed results known after 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.