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Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging

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ClinicalTrials.gov Identifier: NCT01881880
Recruitment Status : Unknown
Verified June 2013 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : June 20, 2013
Last Update Posted : January 9, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Device: Bilateral mammography with Tomosynthesis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging
Study Start Date : December 2012
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Tomosynthesis
Bilateral mammography with 4 views Tomosynthesis
Device: Bilateral mammography with Tomosynthesis
no intervention pre specified to be administered to participants




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multicentricity [ Time Frame: 1 year ]

    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.


  2. performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multifocality [ Time Frame: 1 year ]

    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.




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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881880


Contacts
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Contact: Patrice Taourel +33 467338601 p-taourel@chu-montpellier.fr

Locations
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France
Private Hospital oh Antony Recruiting
Antony, France, 92169
Contact: Pierre Gignier, PH       pgignier@gmail.com   
Sub-Investigator: Pierre Gignier, PH         
UH Grenoble Recruiting
Grenoble, France, 34043
Contact: Delphine Collomb, PH       dcollomb@chu-grenoble.fr   
Sub-Investigator: Delphine Collomb, PH         
Oscar Lambret Center Recruiting
Lille, France, 59000
Contact: Luc Ceugnart, PH    +33 0320295959      
Sub-Investigator: Luc Ceugnart, PH         
Jean Mermoz Hospital Recruiting
Lyon, France, 69008
Contact: Christophe Tourasse, PH       christophe.tourasse@radiologie-lyon.fr   
Sub-Investigator: Christophe Tourasse, PH         
UH Montpellier Recruiting
Montpellier, France, 34295
Contact: Claire Chauveton       c-chauveton@chu-montpellier.fr   
Principal Investigator: Patrice Taourel, PU-PH         
Sub-Investigator: Ingrid Millet, PH         
Hospital Valenciennes Recruiting
Valenciennes, France, 59322
Contact: Edouard Poncelet, PH       poncelet.edouard@gmail.com   
Sub-Investigator: Edouard Poncelet, PH         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Patrice Taourel UH Montpellier

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01881880     History of Changes
Other Study ID Numbers: 8904
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: June 2013
Keywords provided by University Hospital, Montpellier:
Tomosynthesis
Mammography
Breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases