To hear about similar clinical trials, please enter your email below
Trial Title:
Porto-Venous Radiomics in Pancreatic Cancer
NCT ID:
NCT05700110
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
Non-Interventional
Description:
Non-interventional
Summary:
Multi-centre Retrospective Observational Cohort study of patients who underwent
pancreaticoduodenectomy from 01/01/2005 to 01/02/2022 with histologically confirmed
pancreatic head malignancy
Detailed description:
Pancreatic cancers are often inoperable at diagnosis, with only 13-22% of patients being
suitable for surgical resection.1 Surgery is the only curative therapeutic option for
pancreatic cancer and higher rates of long-term patient survival following surgery are
seen in patients where the tumour is completely removed (termed R0 resection). However a
majority of those patients who undergo surgery will develop tumour recurrence at the
primary surgical site or a distant location. The likelihood of cancer recurrence
following surgery increases when there is involvement of major blood vessels that lie
adjacent to the pancreas. This involvement is often microscopic in nature and only
detected after surgery when the surgical specimen is examined microscopically (termed R1
resection). Pre-operative cross-sectional imaging (usually Computed Tomography (CT) is
the standard tool used to assess the risk of R1 resection prior to pancreatic cancer.
However this approach significantly overestimates the number of patients with a
resectable tumour as a significant proportion ultimately have an R1 resection after
surgery. If there is felt to be an increased risk of R1 resection prior to surgery the
patient can be offered oncological treatment prior to surgery to improve the rates of R0
resection that in turn improve long-term patient survival.
The emerging field of Radiomics offers the opportunity to stratify patients undergoing
pancreatic cancer surgery into those at risk of R1 resection prior to surgery. Radiomics
has emerged as a valuable adjunct to medical decision making over the past 10 years. The
basic premise is to extract and analyse large amounts of information not usually visible
to the human eye from medical images, and it is increasingly being used in the field of
cancer diagnostics. The aim of this study is to employ 3D radiomic analyses to
pre-operative CT scan images for cases of pancreatic head cancer that underwent surgical
resection, to determine whether this information could be used to predict R0 and R1
resection margins pre-operatively.
Criteria for eligibility:
Study pop:
Patients on locally maintained patient databases recorded as having undergone a
pancreaticoduodenectomy or Whipple's surgery on or after 01/01/2005 will be screened by
the local clinical team for eligibility.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Patients who underwent pancreaticoduodenectomy/Whipple's surgery for pancreatic head
malignancy between 01/01/2005 and 01/02/2022.
- Pre-operative Computed Tomographic images within 90 days prior to surgical
resection.
- Post-operative histological confirmation of pancreatic ductal adenocarcinoma (PDAC),
ampullary adenocarcinoma (AA), distal bile duct carcinoma (DBC), pancreatic
neuroendocrine tumours (NET/NEC), duodenal adenocarcinoma (DA) or duodenal
gastro-intestinal stromal tumours (GIST).
Exclusion Criteria:
- Postoperative surgical histology confirming benign pathology, metastatic disease or
invasive malignancy arising from sites other than duodenum, pancreatic head or
distal common bile duct.
- Patients who underwent distal pancreatectomy or total pancreatectomy as their
primary surgical procedure.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Royal Marsden NHS Foundation Trust
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Mark Brandon-Grove
Phone:
02031865416
Email:
Mark.Brandon-Grove@rmh.nhs.uk
Investigator:
Last name:
Ricky Mr Bhogal
Email:
Principal Investigator
Start date:
May 5, 2022
Completion date:
May 5, 2024
Lead sponsor:
Agency:
Royal Marsden NHS Foundation Trust
Agency class:
Other
Source:
Royal Marsden NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05700110