Condition category
Cancer
Date applied
08/01/2015
Date assigned
09/01/2015
Last edited
26/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Robert Hanson

ORCID ID

Contact details

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

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

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

Intervention

PET/CT scan. 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

Phase

Drug names

Primary outcome measures

To determine 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

06/01/2011

Overall trial end date

26/04/2013

Reason abandoned

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

Patient

Age group

Adult

Gender

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.

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

United Kingdom

Trial 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
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes