Condition category
Cancer
Date applied
21/08/2019
Date assigned
25/09/2019
Last edited
25/09/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Finding breast cancers early saves lives. Mammograms are the X-ray test that the NHS uses to look for early signs of breast cancer. Mammograms are better at finding some types of breast cancer than others. Unfortunately, fast growing, dangerous cancers are less likely to show up on a mammogram than slow-growing cancers. Also, half the women having breast cancer screening in the UK have enough dense (solid or tightly packed) breast tissue to hide a small cancer on their mammogram. In order to save more lives by finding fast-growing breast cancers early, we need an affordable screening test that is better than mammograms at finding cancers. We also need to know if the NHS staff who read the screening mammograms can quickly learn to interpret the new test accurately. There is a high-tech test (known as MRI) that is better than mammograms at finding breast cancers. However, each MRI scan takes about half an hour, and needs senior medical staff to interpret it. It is therefore expensive and cannot be used for everyone. FAST MRI is a quicker type of MRI that we think could be better than mammograms at finding breast cancers early.
The aim of the study is to see if NHS staff can successfully learn to use a new method of breast cancer screening to find breast cancers early.

Who can participate?
NHS staff who are currently mammogram readers at a participating centre within the NHSBSP service

What does the study involve?
We will teach staff from six NHS centres to interpret FAST MRI. The staff will already be able to read mammograms. Once trained, they will read a set of 125 FAST MRI scans, looking for signs of breast cancer. We want to see how accurate their readings are and find out if our teaching methods are good enough.

What are the possible benefits and risks of participating?
The review by the research ethics committee of our previous single centre study felt that the inclusion of staff within the study as participants could raise ethical issues such as putting pressure on staff to be involved with the study and the way that people’s performance could be presented. Therefore, the ethical issues surrounding a recruitment approach for the readers were considered in depth and led to the production of a participant information sheet about the study and consent forms which have been adapted for the current study and address the issue of coercion at recruitment. The potential risk to staff from the presentation of participants’ performance at the interpretation of FAST MRI dataset task has been minimised by the participants being anonymised for participation in the study. Their performance at FAST MRI is more likely to reflect on the adequacy or otherwise of the training than on their own ability and competence, since they are all current NHS Breast Screening Programme (NHSBSP) mammogram readers (who are all subject to regular audit and quality assurance within the NHSBSP). The principal risk in this study is to participant (staff) confidentiality. We have taken steps to minimise this risk by minimising who has access to the full data set (Chief Investigator and Specialist Researcher (RG), Project Manager and Study Administrator), by using a password-protected Excel document to hold the identifiable details and corresponding anonymised participant identifier, and to keep this Excel file only on an NHS drive within NBT. All other study data will be anonymised before it is made available to the image readers or to the research staff.

Where is the study run from?
North Bristol NHS Trust, Southmead Hospital, UK

When is the study starting and how long is it expected to run for?
October 2019 to August 2020

Who is funding the study?
National Institute for Health Research, UK

Who is the main contact?
1. Sadie McKeown-Keegan (public),
sadie.mckeownkeegan@nbt.nhs.uk
2. Dr Lyn Jones (scientific),
Lyn.Jones@nbt.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Miss Sadie McKeown-Keegan

ORCID ID

Contact details

Breast Care Centre
Southmead Hospital
North Bristol NHS Trust
Westbury on Trym
Bristol
BS10 5NB
United Kingdom
+44 (0) 117 414 9330
sadie.mckeownkeegan@nbt.nhs.uk

Type

Scientific

Additional contact

Dr Lyn Jones

ORCID ID

http://orcid.org/0000-0001-7439-7037

Contact details

Breast Care Centre
Southmead Hospital
North Bristol NHS Trust
Bristol
BS10 5NB
United Kingdom
0117 4147038
Lyn.Jones@nbt.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1.2

Study information

Scientific title

Refinement and piloting of a training programme within the NHS Breast Screening Programme (NHSBSP) workforce of image readers to enable standardised interpretation of a shortened magnetic resonance imaging scan (MRI) of the breast called FAST MRI to support the delivery of a future multicentre trial of FAST MRI versus mammogram for breast cancer screening

Acronym

Study hypothesis

The aim of this study is to refine and pilot a training programme for FAST MRI interpretation within the NHS Breast Screening Programme (NHSBSP) workforce, to support the delivery of a future multicentre study of FAST MRI versus mammogram for breast cancer screening

Ethics approval

Approved 30/08/2019, NHS London-Bromley Research Ethics Committee (Health Research Authority, Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT; +44 (0) 207 104 8063; nrescommittee.london-bromley@nhs.net), ref: 19/LO/1473, IRAS Project ID: 25820

Study design

Interventional pilot study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

See additional files

Condition

Breast Cancer

Intervention

FAST MRI training

Purpose and Design:
Objective 1: To produce a training tool: In our previous study we made a teaching tool that used anonymised FAST MRI images and one to one hands on workstation standardised training including a training script. During the current study we will adapt the current training tool utilising the existing anonymised images and script but incorporating them into an electronic tool that can be delivered to a classroom of up to 10 trainees at once and that automatically measures the time taken to train each trainee.

Objective 2: To deliver the standardised training to multiple NHS staff, from 6 NHS screening centres within the South West Region of England, who are mammogram readers up to a maximum capacity of 100 (which exceeds the number of mammogram readers at these centres). The training will be delivered at one of two sites within region, and 5 consecutive training dates will be offered at each site.

Objective 3: To produce an electronic version of the assessment tool that was used in the previous single centre study that can be used by trained readers, each at their own NHS centre to interpret an existing dataset of anonymised FAST MRI images of 250 breasts.

Objective 4: For trained readers to interpret the existing dataset of anonymised FAST MRI images of 250 breasts. The readers will perform this task over 6 months each at their own NHS centre, aiming to read approximately 20 images at one sitting. Each session is likely to take less than one hour of a reader's time, and therefore approximates to a total of 12 hours of each reader's time to complete the dataset. To read the dataset, the readers who are Consultant Radiologists, Breast Clinicians or Consultant Radiographers will be expected to find time for the interpretation task within their existing Supporting Professional Activity (SpA) time. However, Advanced Practitioners and other filmreading Radiographers are unlikely to have allocated SpA within their job plans and therefore provision has been made within the grant funding to recompense them for the time taken

Data analysis
Each reader will be asked to classify each of the 250 FAST MRI breast scans using the modified version of the MRI screening reporting categories of classification outlined in the 2012 NHSBSP guidelines for screening higher-risk women, where MRI1 and MRI2 indicate normal and benign, MRI3 indicates an indeterminate classification, and MRI4 and MRI5 indicate suspicious and definitely malignant appearances respectively. MRI classification of 4 and 5 will be considered as indicative of cancer. The true outcome result was obtained using the histology of any biopsies or normal results after 3 years of follow-up.
The accuracy of the results from the readers against the true outcome will be determined overall and within each group of readers. In addition, the sensitivity (true positive rate), specificity (true negative rate), false positive and negative rates and the positive and negative predictive values of the readers’ MRI classification with the true outcome will be calculated.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Accuracy of image reading of FAST MRI by trained readers against the marked ground truth

Secondary outcome measures

1. Proportion of image readers completed their training
2. Proportion of readers completed the FAST MRI interpretation task
3. Proportion of readers achieved an acceptable level of accuracy at the task

Overall trial start date

01/11/2018

Overall trial end date

30/09/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Current mammogram readers at a participating centre within the NHSBSP service

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Mammogram readers still undergoing training to read mammograms at the time of recruitment to this study.
2. Image Readers who interpret symptomatic mammograms and/or breast MRIs but who do not read mammograms for NHSBSP

Recruitment start date

01/10/2019

Recruitment end date

01/07/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Cornwall Hospital
Royal Cornwall Hospitals NHS Trust, Treliske
Truro, Cornwall
TR1 3LJ
United Kingdom

Trial participating centre

Great Western Hospital
Marlborough Road
Swindon
SN3 6BB
United Kingdom

Trial participating centre

Musgrove Park Hospital
Parkfield Drive
Taunton
TA1 5DA
United Kingdom

Trial participating centre

Cheltenham Hospital
Sandford Road
Cheltenham
GL53 7AN
United Kingdom

Trial participating centre

North Bristol NHS Trust
Southmead Hospital, Westbury on Trym
Bristol
BS10 5NB
United Kingdom

Trial participating centre

Derriford Hospital
University Hospitals Plymouth NHS Trust Derriford Road
Plymouth
PL6 8DH
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust

Sponsor details

Research & Innovation
North Bristol NHS Trust
Level 3
Learning & Research building
Southmead Hospital
Westbury on Trym
Bristol
BS10 5NB
United Kingdom
0117 414 9330
researchsponsor@nbt.nhs.uk

Sponsor type

Hospital/treatment centre

Website

https://www.nbt.nhs.uk/research-innovation

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The protocol and final results of this study will be published in a high-impact peer reviewed journal. All participants will be offered a summary of results. Results will also be promulgated to our PPI partners and other interested groups.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request (Sadie McKeown-Keegan (Trial Manager) Sadie.Mckeownkeegan@nbt.nhs.uk, the data will become available September 2020, the data will be available until December 2021

Intention to publish date

01/10/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/09/2019: The participant information sheet has been uploaded. 09/09/2019: Trial’s existence confirmed by NHS HRA.