Improving parenchymal phase imaging of the pancreas with multidetector CT using experience from dynamic contrast enhanced MR studies.

ISRCTN	ISRCTN84780767
DOI	https://doi.org/10.1186/ISRCTN84780767
Secondary identifying numbers	N0258161818

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Nandita De Souza
Scientific

Clinical Magnetic Resonance
The Royal Marsden NHS Foundation Trust
Downs Road
Sutton
SM2 5PT
United Kingdom

Phone	+44 (0)20 8661 3289
Email	nandita.desouza@icr.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer: Pancreatic
Intervention	Randomised test intervention vs standardised intervention, non-blinded (Phase III)
Intervention type	Other
Primary outcome measure	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 study start date	19/09/2005
Completion date	30/06/2006
Reason abandoned (if study stopped)	Lack of staff/facilities/resources

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	60
Key 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.
Key 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.
Date of first enrolment	19/09/2005
Date of final enrolment	30/06/2006

Clinical Magnetic Resonance

Sutton
SM2 5PT
United Kingdom

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

The Royal Marsden NHS Foundation Trust

No information available

NHS R&D Support Funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan