Breast CancerNCT01881880
Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging
A study testing Bilateral mammography with Tomosynthesis in people with Breast Cancer, run by University Hospital, Montpellier at 6 sites in France.
Trial summary
Study Rationale: an accurate breast cancer staging has a great impact in the management of a breast cancer. MRI is considered as the most sensible exam for this staging. However it has a low specificity and it may result in extra testing and stress for the patient, add to costs, and delay treatment. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bilateral mammography with Tomosynthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 6 sitesFrance
- Study dates
- 19 Nov 2012to Dec 2015
- 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
- Women at least 40 years old
- Subject with a new lesion recommended for biopsy, whatever the modality which detected the lesion (clinical examination, mammography, tomosynthesis, US, or MRI)
Who cannot join
- Subjects with BRCA mutation or at high genetic risk
- Subjects who have breast implants
- Personal history of breast cancer
- Subjects who are pregnant or who think they may be pregnant
- Subjects who are breast-feeding
- Subjects who are unable or unwilling to tolerate study constraints
- Subjects unable or unwilling to undergo informed consent
- Subject with no rights from the national health insurance programme
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Private Hospital oh Antony
Antony, 92169
UH Grenoble
Grenoble, 34043
Oscar Lambret Center
Lille, 59000
Jean Mermoz Hospital
Lyon, 69008
UH Montpellier
Montpellier, 34295
Hospital Valenciennes
Valenciennes, 59322
About this study
Study Rationale: an accurate breast cancer staging has a great impact in the management of a breast cancer. MRI is considered as the most sensible exam for this staging. However it has a low specificity and it may result in extra testing and stress for the patient, add to costs, and delay treatment. By contrast, Tomosynthesis is performed during the same time than mammography and has a good specificity. Although this modality is very promising, it has not been assessed in a population of consecutive patients.
Study objectives: To compare the diagnostic performance of preoperative bilateral Combo mode (MG+Tomosynthesis) versus mammography among women with breast cancer for the detection of additional multifocal, multicentric, and contralateral cancers.
- Conditions
- Breast Cancer
- Being tested
- Bilateral mammography with Tomosynthesis
- Keywords
- Tomosynthesis, Mammography, Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral mammography with TomosynthesisDevice
no intervention pre specified to be administered to participants
| Study group | Role | What they receive |
|---|---|---|
| Tomosynthesis | Other | Bilateral mammography with 4 views Tomosynthesis Receives: Device: Bilateral mammography with Tomosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic performance of preoperative bilateral Combo mode (MG+Tomosynthesis) versus mammography among women with breast cancer for the detection of additional multifocal, multicentric, and contralateral cancers.
In all sites, Mammography and Tomosynthesis will be standardised and performed according to the Combo mode with 2 views for each breast.
Any additional breast lesion assigned a BI-RAD 4 or 5 score after the full staging work-up will be biopsied under the best imaging method.
(BIRADS scale : BIRADS 4a or higher is considered to be positive for cancer )
The Gold Standard diagnosis is defined as the final diagnosis at 1 year on the basis of the most severe histopathologic result (surgery, biopsy) for that lesion.
A retrospective imaging evaluation of mammography versus Combo mode will be performed for the patients diagnosed with a breast cancer lesion. This retrospective imaging evaluation will be conducted centrally within the assessment committee at the lesion, breast and patient level.
Measured: 1 year
Secondary outcomes (2)
performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multicentricity
Concerning breasts lesions : assessing multicentricity by MG and Combo for the presence of one BI-RADS 4-5 lesions, presence of multifocal BI-RADS 4-5 lesions presence of multicentric BI-RADS 4-5 lesions
A retrospective imaging evaluation of mammography versus Combo mode will be performed for the patients diagnosed with a breast cancer lesion. This retrospective imaging evaluation will be conducted centrally within the assessment committee at the lesion.
Measured: 1 year
performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multifocality
concerning Breasts lesions : assessing multifocality by MG and Combo for the presence of one BI-RADS 4-5 lesions, presence of multifocal BI-RADS 4-5 lesions presence of multicentric BI-RADS 4-5 lesions
A retrospective imaging evaluation of mammography versus Combo mode will be performed for the patients diagnosed with a breast cancer lesion. This retrospective imaging evaluation will be conducted centrally within the assessment committee at the lesion, breast and patient level.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study start19 Nov 2012
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrice Taourel, Principal investigator, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881880
- Sponsor's protocol ID
- 8904
- Status last verified
- Jun 2013
- First submitted
- 22 Mar 2013
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Fontaine M, Tourasse C, Pages E, Laurent N, Laffargue G, Millet I, Molinari N, Taourel P. Local Tumor Staging of Breast Cancer: Digital Mammography versus Digital Mammography Plus Tomosynthesis. Radiology. 2019 Jun;291(3):594-603. doi: 10.1148/radiol.2019182457. Epub 2019 Apr 9.
PubMed 30964425
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging
- ClinicalTrials.gov ID
- NCT01881880
- Acronym / sponsor ID
- 8904
- Conditions
- Breast Cancer
- Keywords
- Tomosynthesis, Mammography, Breast cancer
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 424 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Nov 2012 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Jun 2013 (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.
Study Rationale: an accurate breast cancer staging has a great impact in the management of a breast cancer. MRI is considered as the most sensible exam for this staging. However it has a low specificity and it may result in extra testing and stress for the patient, add to costs, and delay treatment. By contrast, Tomosynthesis is performed during the same time than mammography and has a good specificity. Although this modality is very promising, it has not been assessed in a population of consecutive patients.
Study objectives: To compare the diagnostic performance of preoperative bilateral Combo mode (MG+Tomosynthesis) versus mammography among women with breast cancer for the detection of additional multifocal, multicentric, and contralateral cancers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tomosynthesis | Other | Device: Bilateral mammography with TomosynthesisBilateral mammography with 4 views Tomosynthesis |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women at least 40 years old
- Subject with a new lesion recommended for biopsy, whatever the modality which detected the lesion (clinical examination, mammography, tomosynthesis, US, or MRI)
Key exclusion criteria (8 listed)
- Subjects with BRCA mutation or at high genetic risk
- Subjects who have breast implants
- Personal history of breast cancer
- Subjects who are pregnant or who think they may be pregnant
- Subjects who are breast-feeding
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 |
|---|---|---|
| Bilateral mammography with Tomosynthesisno intervention pre specified to be administered to participants | Device | Tomosynthesis |
Primary outcome
diagnostic performance of preoperative bilateral Combo mode (MG+Tomosynthesis) versus mammography among women with breast cancer for the detection of additional multifocal, multicentric, and contralateral cancers.
Time frame: 1 year
In all sites, Mammography and Tomosynthesis will be standardised and performed according to the Combo mode with 2 views for each breast. Any additional breast lesion assigned a BI-RAD 4 or 5 score after the full staging work-up will be biopsied under the best imaging method. (BIRADS scale : BIRADS 4a or higher is considered to be positive for cancer ) The Gold Standard diagnosis is defined as the final diagnosis at 1 year on the basis of the most severe histopathologic result (surgery, biopsy) for that lesion. A retrospective imaging evaluation of mammography versus Combo mode will be performed for the patients diagnosed with a breast cancer lesion. This retrospective imaging evaluation will be conducted centrally within the assessment committee at the lesion, breast and patient level.
2 secondary outcomes
performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multicentricity
Time frame: 1 year
performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multifocality
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Derived from this study: PubMed 30964425Fontaine M, Tourasse C, Pages E, Laurent N, Laffargue G, Millet I, Molinari N, Taourel P. Local Tumor Staging of Breast Cancer: Digital Mammography versus Digital Mammography Plus Tomosynthesis. Radiology. 2019 Jun;291(3):594-603. doi: 10.1148/radiol.2019182457. Epub 2019 Apr 9.
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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.
Patrice Taourel principal investigator
UH Montpellier
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral mammography with Tomosynthesis in people with Breast Cancer, run by University Hospital, Montpellier at 6 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 was stopped early. Results are not available in the source record.
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?
diagnostic performance of preoperative bilateral Combo mode (MG+Tomosynthesis) versus mammography among women with breast cancer for the detection of additional multifocal, multicentric, and contralateral cancers. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01881880, which also lists 1 linked publication.
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 29 May 2024.