Digital breast tomosynthesis in screening younger higher risk women

ISRCTN	ISRCTN37806452
DOI	https://doi.org/10.1186/ISRCTN37806452
Secondary identifying numbers	16312

Submission date: 03/04/2014
Registration date: 03/04/2014
Last edited: 23/04/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

http://www.cancerresearchuk.org/about-cancer/trials/a-study-comparing-digital-breast-tomosynthesis-standard-mammogram-screening-younger-high-risk-women

Contact information

Ms Amanda Rees
Scientific

Genesis Prevention Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Email	amanda.rees@uhsm.nhs.uk

Study information

Study design	Randomised; Interventional; Design type: Screening
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format. Please use contact details below to request a patient information sheet
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
Study 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(s)	14/NW/0053; First MREC approval date 19/02/2014
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
Primary outcome measure	Recall to assessment rate; Timepoint(s): At screening
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/04/2014
Overall study end date	30/09/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Planned Sample Size: 2904; UK Sample Size: 2904
Total final enrolment	1227
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 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

England
United Kingdom

Study participating centre

Genesis Prevention Centre

Manchester
M23 9LT
United Kingdom

Sponsor information

University Hospital of South Manchester (UK)
Hospital/treatment centre

Wythenshawe Hospital, Southmoor Road
Wythenshawe
Manchester
M23 9LT
England
United Kingdom

"ROR"	https://ror.org/00he80998

Funders

Funder type

Charity

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results		23/04/2021	No	Yes
Results article	01/09/2017	23/04/2021	Yes	No
HRA research summary		28/06/2023	No	No

Editorial Notes

23/04/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.