Condition category
Cancer
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
15/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes