Condition category
Cancer
Date applied
27/09/2017
Date assigned
29/11/2017
Last edited
16/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Public

Primary contact

Mr Jonathan Evans

ORCID ID

Contact details

Level 7
Queens Building
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2.0

Study information

Scientific title

Evaluation of multi-parametric magnetic resonance imaging for characterising lymph node status, peritoneal and liver metastasis in pancreatic cancer

Acronym

Evaluate

Study hypothesis

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

South West - Central Bristol Research Ethics Committee, 20/06/2016, re: 16/SW/0105

Study design

Single-centre proof-of-principle diagnostic accuracy study

Primary study design

Observational

Secondary study design

Diagnostic accuracy study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/09/2016

Overall trial end date

01/09/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient ≥ 18 years
2. Confirmed or suspected pancreatic cancer referred for pancreaticoduodenectomy
3. Fit for general anaesthesia
4. Signed informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant 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)

Recruitment start date

01/09/2016

Recruitment end date

01/09/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals Bristol NHS Foundation Trust
BS2 8HW

Sponsor information

Organisation

University Hospitals Bristol NHS Foundation Trust

Sponsor details

Bristol Royal Infirmary
Upper Maudlin St
Bristol
BS2 8HW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.uhbristol.nhs.uk/research-innovation

Funders

Funder type

Charity

Funder name

David Telling Charitable Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
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.

Intention to publish date

01/06/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/01/2018: Internal review.