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Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bilateral mammography with Tomosynthesis
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Tomosynthesis, Mammography, Breast cancer

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Private Hospital oh AntonyRecruiting
  • UH GrenobleRecruiting
  • Oscar Lambret CenterRecruiting
  • Jean Mermoz HospitalRecruiting
  • UH MontpellierRecruiting
  • Hospital ValenciennesRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Tomosynthesis

Arm Description

Bilateral mammography with 4 views Tomosynthesis

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 22, 2013
Last Updated
January 8, 2015
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT01881880
Brief Title
Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging
Official Title
Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Tomosynthesis, Mammography, Breast cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tomosynthesis
Arm Type
Other
Arm Description
Bilateral mammography with 4 views Tomosynthesis
Intervention Type
Device
Intervention Name(s)
Bilateral mammography with Tomosynthesis
Intervention Description
no intervention pre specified to be administered to participants
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multicentricity
Description
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.
Time Frame
1 year
Title
performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multifocality
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrice Taourel
Phone
+33 467338601
Email
p-taourel@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrice Taourel
Organizational Affiliation
UH Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private Hospital oh Antony
City
Antony
ZIP/Postal Code
92169
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Gignier, PH
Email
pgignier@gmail.com
First Name & Middle Initial & Last Name & Degree
Pierre Gignier, PH
Facility Name
UH Grenoble
City
Grenoble
ZIP/Postal Code
34043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine Collomb, PH
Email
dcollomb@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Delphine Collomb, PH
Facility Name
Oscar Lambret Center
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc Ceugnart, PH
Phone
+33 0320295959
First Name & Middle Initial & Last Name & Degree
Luc Ceugnart, PH
Facility Name
Jean Mermoz Hospital
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Tourasse, PH
Email
christophe.tourasse@radiologie-lyon.fr
First Name & Middle Initial & Last Name & Degree
Christophe Tourasse, PH
Facility Name
UH Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Chauveton
Email
c-chauveton@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Patrice Taourel, PU-PH
First Name & Middle Initial & Last Name & Degree
Ingrid Millet, PH
Facility Name
Hospital Valenciennes
City
Valenciennes
ZIP/Postal Code
59322
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edouard Poncelet, PH
Email
poncelet.edouard@gmail.com
First Name & Middle Initial & Last Name & Degree
Edouard Poncelet, PH

12. IPD Sharing Statement

Citations:
PubMed Identifier
30964425
Citation
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.
Results Reference
derived

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Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging

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