Breast CancerTOMOSEINNCT01612650
Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis
A study testing tomosynthesis and 2D mammography in people with Breast Cancer and 2D Mammography, run by Centre Oscar Lambret at 4 sites in France.
Trial summary
This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure) Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer, 2D Mammography, 3D Mammography
- What is being tested?
- tomosynthesis and 2D mammography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,069 participants
- Where
- 4 sitesFrance
- Study dates
- 24 Feb 2012to 16 Mar 2017
- Phase
- Interventional
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- woman with breast cancer histologically proven (group 1), on surveillance of a treated breast cancer (group 2) or diagnosis of an detected anomaly
- age ≥ 40 years (group 1, group 2); age ≥ 50 years (group 3)
- breast size suitable for detector size
- possible prior mastectomy
- security social covered
- signed informed consent
Who cannot join
- breast implant
- high genetic risk (mutation)
- under justice measures
- breast feeding or pregnant woman
Trial locations and contacts
4 sites in 1 country.
France4 sites
Oscar Lambret Center
Lille, 59020
Centre Hospitalier - Pavillon Paul Gelé
Roubaix, 59100
Centre Hospitalier
Valenciennes, 59300
Clinique des Dentellières
Valenciennes, 59300
About this study
This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure)
- Conditions
- Breast Cancer, 2D Mammography, 3D Mammography
- Being tested
- tomosynthesis, 2D mammography
- Keywords
- breast cancer, surveillance, diagnosis, 2D mammography, 3D mammography
- Medical subject headings
- Breast Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tomosynthesisDevice
2 incidences 3D numeric mammography
2D mammographyDevice
2 incidences 2D analogic mammography
| Study group | Role | What they receive |
|---|---|---|
| breast cancer histologically proven | Active comparator | Patient with breast cancer histologically proven, addressed to Oscar Lambret Center for treatment Receives: Device: tomosynthesis; Device: 2D mammography |
| surveillance of a treated breast cancer | Active comparator | surveillance of patient already treated for breast cancer must have annual mammography Receives: Device: tomosynthesis; Device: 2D mammography |
| diagnosis of a detected anomaly | Active comparator | patient addressed for diagnosis of a detected anomaly Receives: Device: tomosynthesis; Device: 2D mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine the benefit of tomosynthesis for diagnosis
number of avoided focused cliches and ultrasound, after tomosynthesis analysis
Measured: 30 months
Secondary outcomes (4)
determine best incidence of realization
face, medial side or oblique
Measured: 30 months
measurement of breast irradiation
comparison of tomosynthesis irradiation and focused cliches irradiation
Measured: 30 months
evaluate non focused ultrasound residual place for 2 - 3 - 4 density breast
Measured: 30 months
number of additional cancer detected by tomosynthesis
number of breast cancer detected through tomosynthesis
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study start24 Feb 2012
- Primary completion16 Mar 2017
- Study completion16 Mar 2017
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,069 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie TAIEB, MD, Principal investigator, Oscar Lambret Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612650
- Sponsor's protocol ID
- TOMOSEIN-1104
- Other IDs
- 2011-002051-34
- Acronym
- TOMOSEIN
- Status last verified
- Mar 2018
- First submitted
- 4 Jun 2012
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis
- ClinicalTrials.gov ID
- NCT01612650
- Acronym / sponsor ID
- TOMOSEIN / TOMOSEIN-1104
- Conditions
- Breast Cancer, 2D Mammography, 3D Mammography
- Keywords
- breast cancer, surveillance, diagnosis, 2D mammography, 3D mammography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,069 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 24 Feb 2012 (actual)
- Primary completion
- 16 Mar 2017 (actual)
- Study completion
- 16 Mar 2017 (actual)
- First posted
- 6 Jun 2012 (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 aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure)
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| breast cancer histologically proven | Active comparator | Device: tomosynthesis, Device: 2D mammographyPatient with breast cancer histologically proven, addressed to Oscar Lambret Center for treatment |
| surveillance of a treated breast cancer | Active comparator | Device: tomosynthesis, Device: 2D mammographysurveillance of patient already treated for breast cancer must have annual mammography |
| diagnosis of a detected anomaly | Active comparator | Device: tomosynthesis, Device: 2D mammographypatient addressed for diagnosis of a detected anomaly |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- woman with breast cancer histologically proven (group 1), on surveillance of a treated breast cancer (group 2) or diagnosis of an detected anomaly
- age ≥ 40 years (group 1, group 2); age ≥ 50 years (group 3)
- breast size suitable for detector size
- possible prior mastectomy
- security social covered
Key exclusion criteria (4 listed)
- breast implant
- high genetic risk (mutation)
- under justice measures
- breast feeding or pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tomosynthesis2 incidences 3D numeric mammography | Device | breast cancer histologically proven, diagnosis of a detected anomaly, surveillance of a treated breast cancer |
| 2D mammography2 incidences 2D analogic mammography | Device | breast cancer histologically proven, diagnosis of a detected anomaly, surveillance of a treated breast cancer |
Primary outcome
determine the benefit of tomosynthesis for diagnosis
Time frame: 30 months
number of avoided focused cliches and ultrasound, after tomosynthesis analysis
4 secondary outcomes
determine best incidence of realization
Time frame: 30 months
measurement of breast irradiation
Time frame: 30 months
evaluate non focused ultrasound residual place for 2 - 3 - 4 density breast
Time frame: 30 months
number of additional cancer detected by tomosynthesis
Time frame: 30 months
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 23 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Sophie TAIEB, MD principal investigator
Oscar Lambret Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tomosynthesis and 2D mammography in people with Breast Cancer and 2D Mammography, run by Centre Oscar Lambret at 4 sites in France.
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 6 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 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
determine the benefit of tomosynthesis for diagnosis (time frame: 30 months). 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 23 Mar 2018.