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
Protocol serial number N0258161818
Sponsor Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders The Royal Marsden NHS Foundation Trust, NHS R&D Support Funding
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
15/05/2012
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Cancer
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

Contact information

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 information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific title
Study objectivesTo 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) studiedCancer: Pancreatic
InterventionRandomised test intervention vs standardised intervention, non-blinded (Phase III)
Intervention typeOther
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date30/06/2006
Reason abandoned (if study stopped)Lack of staff/facilities/resources

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration60
Key inclusion criteria1. 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 criteria1. 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 enrolment19/09/2005
Date of final enrolment30/06/2006

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Clinical Magnetic Resonance
Sutton
SM2 5PT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes