Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Contact information



Primary contact

Mr Robert Hanson


Contact details

University of Liverpool
Cancer Research UK Liverpool Cancer Trials Unit
200 London Road
L3 9TA
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


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



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

NRES Committee North West - GM East (Cheshire), 18/03/2010, ref: 10/H1017/8

Study design

Non-randomised; Interventional

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Topic: Cancer, Surgery; Subtopic: Upper Gastro-Intestinal Cancer, Surgery; Disease: Pancreas


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



Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Participant exclusion criteria

1. Patients younger than 18 years
2. Pregnancy
3. Patients with poorly controlled diabetes

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Liverpool
Cancer Research UK Liverpool Cancer Trials Unit 200 London Road
L3 9TA
United Kingdom

Sponsor information


University of Liverpool

Sponsor details

Foresight Centre
1-3 Brownlow Street
L69 3GL
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2018 results in

Publication citations

Additional files

Editorial Notes

24/05/2019: The following changes were made to the trial record: 1. Added CRUK link to results (plain English). 2. The total final enrolment was added. 06/06/2017: No publications found, verifying study status with principal investigator.