Digital Breast Tomosynthesis in Younger Symptomatic Women | NCT01241981

Studies
Digital Breast Tomosynthesis in Younger Symptomatic Women

NCT01241981

Sponsor

NHS Tayside

Status

Completed

Last Update Posted

May 8, 2018Actual

Enrollment

446Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Dec 21, 2016Actual

Completion Date

Feb 28, 2018Actual

First Submitted Date

Nov 15, 2010

First Submission Date that Met QC Criteria

Nov 15, 2010

First Posted Date

Nov 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2018

Last Update Posted Date

May 8, 2018Actual

Name	Class
University of Dundee	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will examine a new imaging technique called digital breast tomosynthesis (DBT) compared to standard mammography in women under 60 presenting with signs of breast cancer. The reason that we need to do this study is that standard mammography fails to detect the cancer in approximately 20% of these women because younger women have denser breast tissue. We hope that DBT will be more sensitive in detecting breast cancer than standard mammography.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

446Actual

Label	Type	Description	Intervention Names
Digital Breast Tomosynthesis		Digital Breast Tomosynthesis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity of DBT for breast cancer, compared with FFDM		Two years

Secondary Outcomes

Measure	Description	Time Frame
Accuracy of DBT compared with FFDM in assessment of tumour extent		Two years
Relative accuracy of DBT and FFDM by breast density		Two years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female
Under 60 years old
Clinical or ultrasound suspicion of breast cancer

Exclusion Criteria:

Unable to give informed consent
Male
Obvious advanced breast cancer
Obvious medical problems meaning surgery would not be an option

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

59 Years

Standard Ages

ChildAdult

Study Population

Women under 60 years of age with clinical or ultrasound suspicion of breast cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew J Evans, FRCR	University of Dundee, NHS Tayside	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NHS Tayside, Ninewells Hospital & Medical School		Dundee	Tayside	DD1 9SY	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D009369	Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided