Condition category
Cancer
Date applied
03/04/2014
Date assigned
03/04/2014
Last edited
16/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Amanda Rees

ORCID ID

Contact details

Genesis Prevention Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
amanda.rees@uhsm.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16312

Study information

Scientific title

A randomised trial of screening with digital breast tomosynthesis plus conventional digital 2D mammography versus 2D mammography alone in women aged 40 to 49 at increased risk of breast cancer

Acronym

FHtomo

Study hypothesis

Mammographic screening is performed to detect breast cancer. Tomosynthesis is a new way of performing mammography that uses x-rays and a computer to generate three-dimensional (3D) images of the breast. The purpose of this study is to compare the accuracy of tomosynthesis and standard 2D mammography in the diagnosis of breast abnormalities, and in particular whether tomosynthesis can reduce the number of ‘false alarms’ which lead to further tests.

Ethics approval

14/NW/0053; First MREC approval date 19/02/2014

Study design

Randomised; Interventional; Design type: Screening

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format. Please use contact details below to request a patient information sheet

Condition

Topic: Cancer; Subtopic: Breast Cancer; Disease: Breast

Intervention

Participants who have not had a screening mammogram before will have a standard 2D mammogram and DBT.

Women who have undergone screening mammography prior to entering the trial will be randomised using a web-based randomisation service to undergo either standard 2D mammography only followed a year later by 2D mammography and DBT, or the reverse (i.e. 2D mammography and DBT followed a year later by 2D mammography only). Participants will return to the standard screening schedule in the Family History Clinic following the trial.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Recall to assessment rate; Timepoint(s): At screening

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2014

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Women aged 40 to 49 years inclusive with an increased risk of breast cancer by virtue of their family history and who have been referred for screening by a family history or genetics service.
(Note some women will be aged 50 when they have their second screen within the study)
Target Gender: Female; Upper Age Limit 50 years ; Lower Age Limit 40 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 2904; UK Sample Size: 2904

Participant exclusion criteria

1. Inability to give informed consent, including inability to understand the nature and purpose of the study
2. Breast implants
3. Pregnancy
4. Previous breast cancer

Recruitment start date

01/04/2014

Recruitment end date

30/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Genesis Prevention Centre
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

University Hospital of South Manchester (UK)

Sponsor details

Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Genesis Breast Cancer Prevention Appeal Ltd (UK); Grant Codes: GA13-007

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