Breast CancerNCT01241981
Digital Breast Tomosynthesis in Younger Symptomatic Women
An observational study of Breast Cancer, run by NHS Tayside at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 59 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 446 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to 28 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 59 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Women under 60 years of age with clinical or ultrasound suspicion of breast cancer
Who may be able to join
- Female
- Under 60 years old
- Clinical or ultrasound suspicion of breast cancer
Who cannot join
- Unable to give informed consent
- Male
- Obvious advanced breast cancer
- Obvious medical problems meaning surgery would not be an option
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NHS Tayside, Ninewells Hospital & Medical School
Dundee, Tayside, DD1 9SY
About this study
Official title: Digital Breast Tomosynthesis (DBT): Sensitivity for Cancer and Accuracy in Assessing Extent of Malignant Disease in Symptomatic Women Below 60 With Clinical or Ultrasound Signs Compatible With Malignancy
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.
- Conditions
- Breast Cancer
- Keywords
- Breast, Cancer, Digital, Mammography, Tomosynthesis
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Digital Breast Tomosynthesis | Digital Breast Tomosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of DBT for breast cancer, compared with FFDM
Measured: Two years
Secondary outcomes (2)
Accuracy of DBT compared with FFDM in assessment of tumour extent
Measured: Two years
Relative accuracy of DBT and FFDM by breast density
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startMar 2011
- Primary completion21 Dec 2016
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Tayside
- Sponsor type
- Other government
- Collaborators
- University of Dundee
- Responsible party
- Principal investigator, Andy Evans, NHS Tayside
- Investigators
- Andrew J Evans, FRCR, Principal investigator, University of Dundee, NHS Tayside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241981
- Sponsor's protocol ID
- 2010ON15
- Status last verified
- May 2018
- First submitted
- 15 Nov 2010
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Breast Tomosynthesis (DBT): Sensitivity for Cancer and Accuracy in Assessing Extent of Malignant Disease in Symptomatic Women Below 60 With Clinical or Ultrasound Signs Compatible With Malignancy
- ClinicalTrials.gov ID
- NCT01241981
- Acronym / sponsor ID
- 2010ON15
- Conditions
- Breast Cancer
- Keywords
- Breast, Cancer, Digital, Mammography, Tomosynthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- NHS TaysideOther government
- Collaborators
- University of Dundee
- Study start
- Mar 2011
- Primary completion
- 21 Dec 2016 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Breast Tomosynthesis | – | –Digital Breast Tomosynthesis |
Who may qualify
- Ages
- Up to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Women under 60 years of age with clinical or ultrasound suspicion of breast cancer
Key inclusion criteria (3 listed)
- Female
- Under 60 years old
- Clinical or ultrasound suspicion of breast cancer
Key exclusion criteria (4 listed)
- Unable to give informed consent
- Male
- Obvious advanced breast cancer
- Obvious medical problems meaning surgery would not be an option
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of DBT for breast cancer, compared with FFDM
Time frame: Two years
2 secondary outcomes
Accuracy of DBT compared with FFDM in assessment of tumour extent
Time frame: Two years
Relative accuracy of DBT and FFDM by breast density
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J Evans, FRCR principal investigator
University of Dundee, NHS Tayside
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by NHS Tayside at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of DBT for breast cancer, compared with FFDM (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.