Plain English Summary
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
8166
Study information
Scientific title
The impact of combined modality positron emission tomography with computerised tomography scanning (PET/CT) in the diagnosis and management of pancreatic cancer
Acronym
PET-PANC
Study hypothesis
The diagnosis of pancreatic cancer has improved with the use of multidetector CT, EUS, ERCP and additional use of MRI. There are, however, up to 10-20% of patients in whom an accurate diagnosis is difficult. This proportion is increasing due in part to larger numbers of asymptomatic patients undergoing cross sectional imaging. Invasive methods of diagnosis such as EUS +/- FNA can add to the accuracy of multidetector CT but may require an in-patient stay and have a recognised complication rate (1-2%). Currently patients with chronic pancreatitis, autoimmune pancreatitis, cystic lesions, small tumours <2cm, a bulky or diffusely enlarged pancreas on CT, a dilated pancreatic duct and no mass on CT, small volume metastatic disease and suspected recurrent disease (with no mass on CT) following resection are the most challenging patients to diagnose. A major goal of accurate diagnosis and staging is to avoid major pancreatic resection in patients who will not benefit. The use of a functional imaging technique such as PET/CT may add to staging of pancreatic cancer by diagnosing small volume metastatic disease and differentiate between benign and malignant lesions. Earlier diagnosis of pancreatic cancer will lead to a better prognosis for patients and PET/CT may be able to identify small volume disease or cancer arising in patients with chronic pancreatitis. There have been a number of studies to address diagnostic accuracy of PET/CT and two have looked at the issue of changes in management due to PET/CT. The main drawbacks of previous PET/CT studies tend to be that these are single centre studies with small numbers of patients and difficulties in standardising PET/CT protocol in pancreatic cancer. This prospective multicentre study aims to address these issues in a large group of patients to identify whether there is a role for PET/CT in addition to standard diagnostic work up in pancreatic cancer.
Ethics approval(s)
NRES Committee North West - GM East (Cheshire), 18/03/2010, ref: 10/H1017/8
Study design
Non-randomised; Interventional
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Cancer, Surgery; Subtopic: Upper Gastro-Intestinal Cancer, Surgery; Disease: Pancreas
Intervention
Combined modality positron emission tomography with computerised tomography scanning (PET/CT) in the diagnostic work up of patients with suspected pancreatic malignancy; Follow up length: 12 month(s).
Intervention type
Procedure/Surgery
Primary outcome measure
The incremental diagnostic accuracy and impact of PET/CT to standard diagnostic work up; Timepoint(s): Outcome time point will be assessed after 12 Months of follow up
Secondary outcome measures
1. Determine cost effectiveness of addition of PET/CT in diagnosis, staging and management.; Timepoint(s): After 12 months follow up
2. Evaluate addition of PET/CT in differentiating pancreatic malignancy from chronic pancreatitis; Timepoint(s): After 12 months follow up
3. Evaluate change in diagnosis, staging and intended patient management through the addition of PET/CT; Timepoint(s): After 12 months follow up
4. Report the incremental diagnostic value of PET/CT for particular types of pancreatic tumour; Timepoint(s): After 12 months follow up
5. To identify which groups of patients would most benefit from PET/CT; Timepoint(s): After 12 months follow up
Overall study start date
06/01/2011
Overall study end date
26/04/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with suspected pancreatic malignancy as defined by one or more of:
1.1. Focal lesion in the pancreas/bulky pancreas/dilated pancreatic duct (+/- metastases) detected on Multidetector CT scan (+/- MRI/EUS/USS)
1.2. Jaundice due to distal obstruction of the common bile duct or ampulla (not due to calculi) defined as serum bilirubin. 35 µmol/l
1.3. Serum CA19.9 value above 37KU/l
2. Able to attend for PET/CT scan
3. Able to undergo Multidetector CT scan
4. Able to attend for up to 12 months follow-up
5. Fully informed written consent given
6. Gender: Male & Female
7. Lower Age Limit 18 years
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
Planned Sample Size: 600; UK Sample Size: 600; Description: Final sample size to be confirmed after interim analysis following recruitment of 200 patients.
Total final enrolment
589
Participant exclusion criteria
1. Patients younger than 18 years
2. Pregnancy
3. Patients with poorly controlled diabetes
Recruitment start date
06/01/2011
Recruitment end date
26/04/2013
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
University of Liverpool
Cancer Research UK Liverpool Cancer Trials Unit
200 London Road
Liverpool
L3 9TA
United Kingdom
Sponsor information
Organisation
University of Liverpool
Sponsor details
Foresight Centre
1-3 Brownlow Street
Liverpool
L69 3GL
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 01/02/2018 | Yes | No |