Contact information
Type
Scientific
Primary contact
Dr Nandita De Souza
ORCID ID
Contact details
Clinical Magnetic Resonance
The Royal Marsden NHS Foundation Trust
Downs Road
Sutton
SM2 5PT
United Kingdom
+44 (0)20 8661 3289
nandita.desouza@icr.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0258161818
Study information
Scientific title
Acronym
Study hypothesis
To improve the diagnosis of pancreatic cancer by exploiting technology available on newer CT scanners to improve the enhancement of normal pancreatic tissue.
As of 15/05/2012, the anticipated end date for this trial has been updated from 18/04/2006 to 30/06/2006.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cancer: Pancreatic
Intervention
Randomised test intervention vs standardised intervention, non-blinded (Phase III)
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
1. Absolute value of the Hounsfield attenuation in normal pancreatic tissue at pancreatic parenchymal phase.
2. Clinical radiologist's impression on the utility/benefit of mucosal enhancement of adjacent duodenum in aiding local staging.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
19/09/2005
Overall trial end date
30/06/2006
Reason abandoned
Lack of staff/facilities/resources
Eligibility
Participant inclusion criteria
1. Age over 18 - pancreatic adenocarcinoma is unusual below this age and children are more sensitive to additional ionising radiation than adults
2. Stage III ovarian cancer or colorectal cancer
3. Routine attendance for contrast enhanced abdominal CT - no patients not otherwise having CT and contrast will be approached.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Severe local disease affecting pancreatic aorta/branches. This may introduce delays to the arrival of contrast due to compromise of arteries (SMA/Coeliac axis)
2. Major atherosclerotic disease of SMA/Coeliac axis - again, to avoid significant delay in contrast path distal to pancreatic aorta
3. Significant pancreatic resection - absence of normal pancreatic tissue will preclude our numerical assessment of enhancement
4. Pre-existing pancreatic disease - cancer or pancreatitis.
Recruitment start date
19/09/2005
Recruitment end date
30/06/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Magnetic Resonance
Sutton
SM2 5PT
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Royal Marsden NHS Foundation Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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