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
Scientific
Clinical Magnetic Resonance
The Royal Marsden NHS Foundation Trust
Downs Road
Sutton
SM2 5PT
United Kingdom
| Phone | +44 (0)20 8661 3289 |
|---|---|
| nandita.desouza@icr.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
1. Absolute value of the Hounsfield attenuation in normal pancreatic tissue at pancreatic parenchymal phase. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2006 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Clinical Magnetic Resonance
Sutton
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |