Peroperative Assessment of Tumour Resection Margins Using High-resolution 18F-FDG-PET/CT in Pancreatic Adenocarcinoma

NCT05023291 | Terminated

• 1 other identifier: BC-05923
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fluorodeoxyglucose F18

Outcome Measures

Primary Outcomes (1)

• 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.

  marge assessment immediately performed results known after 3 weeks

Study Arms (1)

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.

Diagnostic Test: Positron Emissie Tomografie - Computer Tomografie

Interventions

Positron Emissie Tomografie - Computer Tomografie DIAGNOSTIC_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.

test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥ 18 years)
• Signed informed consent
• Patient with a Pancreas Ca who is undergoing Whipple surgery
• Patient with ASA grade 1 to 3

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, East-flanders, 9000, Belgium

Location

Study Officials

• Frederik Berrevoet, MD-PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

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: August 24, 2020
• First Posted: August 26, 2021
• Study Start: March 30, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)