Evaluate - can magnetic resonance imaging (MRI) pick up early tumour spread in pancreatic cancer?
| ISRCTN | ISRCTN15395684 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15395684 |
| Secondary identifying numbers | 2.0 |
- Submission date
- 27/09/2017
- Registration date
- 29/11/2017
- Last edited
- 13/06/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Mr Jonathan Evans
Public
Public
Level 7, Queens Building
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
Study information
| Study design | Single-centre proof-of-principle diagnostic accuracy study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Diagnostic accuracy study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Evaluation of multi-parametric magnetic resonance imaging for characterising lymph node status, peritoneal and liver metastasis in pancreatic cancer |
| Study acronym | Evaluate |
| Study objectives | The overall study aim is to determine whether multi parametric MRI can identify lymph node, peritoneal and liver metastasis in patients referred for pancreaticoduodenectomy (surgery for pancreatic cancer), and to determine whether MRI can ‘diagnose’ resectability (i.e. identifies patients in whom the surgery should not go ahead). |
| Ethics approval(s) | South West - Central Bristol Research Ethics Committee, 20/06/2016, re: 16/SW/0105 |
| Health condition(s) or problem(s) studied | Pancreatic cancer |
| Intervention | All patients will attend the CRIC for a a multi-parametric MRI scan roughly 2 weeks before their surgery (index test); the MRI scan will not be reported and the images will not be made available to the care team. During surgery (usual care), a visual examination, intraoperative ultrasound and/or frozen section intraoperative biopsy with histopathology assessment will be carried out and the operating team will decide whether to resect or not (without inspecting the MRI scan). The MRI will be assessed after the patients have had their surgical treatment (either the Whipple’s procedure or not) and the doctors reporting the scans will not know what treatment the patient has had or the results of any other tests. The doctors will attempt to identify from the MRI scan whether the cancer has spread to lymph nodes, the liver and abdomen, and make a decision based on the MRI as to whether the patient should have been referred for surgery or not. The decision to proceed with the surgery or not based on the MRI scan will then be compared with the same decision made by the surgeon at surgery. |
| Intervention type | Other |
| Primary outcome measure | Proportion of patients correctly identified by MRI as being ‘resectable’ (no lymph node, peritoneal or liver metastases) as determined by sensitivity and positive predictive values (PPV). Data collected at surgery (whether resection for pancreatic cancer goes ahead or not) and the preoperative MRI scan (whether metastases are identified or not). |
| Secondary outcome measures | Data collected at surgery and the preoperative MRI scan: 1. Proportion of patients correctly identified by MRI to have lymph node, peritoneal or liver metastases. Position of ‘pathological’ lymph nodes on MRI is correlated with the final histology 2. Intra- and inter-observer reliability of MRI 3. Optimal combination of MRI parameters to detect metastasis 4. Safety of MRI in this patient population 5. Feasibility parameters (recruitment) 6. Resource use and costs for a preliminary economic evaluation, collected during the patient’s hospital stay 7. Vital status of participants for 5 years after the last patient is recruited |
| Overall study start date | 01/09/2016 |
| Completion date | 01/09/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Patient ≥ 18 years 2. Confirmed or suspected pancreatic cancer referred for pancreaticoduodenectomy 3. Fit for general anaesthesia 4. Signed informed consent |
| Key exclusion criteria | 1. Prisoners and adults lacking capacity to consent 2. Patients undergoing distal or total pancreatectomy 3. Contraindications to MR (implanted electronic devices, metallic foreign bodies, claustrophobia, body weight >140 kg or waist perimeter exceeding manufacturer‘s recommendations and others according to manufacturer’s recommendations and generally accepted guidelines) |
| Date of first enrolment | 01/09/2016 |
| Date of final enrolment | 01/09/2019 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
University Hospitals Bristol NHS Foundation Trust
BS2 8HW
Sponsor information
University Hospitals Bristol NHS Foundation Trust
Hospital/treatment centre
Hospital/treatment centre
Bristol Royal Infirmary
Upper Maudlin St
Bristol
BS2 8HW
England
United Kingdom
| Website | http://www.uhbristol.nhs.uk/research-innovation |
|---|
Funders
Funder type
Charity
David Telling Charitable Trust
No information available
Results and Publications
| Intention to publish date | 01/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study protocol can be made available on request (email: maria.pufulete@bristol.ac.uk). Planned publication of the study results in a high-impact peer-reviewed journal around June 2020. |
| IPD sharing plan | Anonymised individual patient data can be made available for secondary research (please contact maria.pufulete@bristol.ac.uk) when the study is complete and analysed (June 2020), conditional on assurance from the secondary researcher that the proposed use of the data is compliant with the MRC Policy on Data Preservation and Sharing regarding scientific quality, ethical requirements and value for money. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/06/2018: Cancer Research UK lay summary link added to plain English summary field
14/05/2018: Internal review.
16/01/2018: Internal review.
