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Breast Cancer Screening: Digital Breast Tomosynthesis Versus Digital 2D Mammography (TOSYMA)

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ClinicalTrials.gov Identifier: NCT03377036
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
University Hospital Muenster

Brief Summary:
This study is a randomized, multicenter, multivendor, controlled, diagnostic superiority trial to compare digital breast tomosynthesis plus synthesized 2D mammograms (DBT+s2D) versus standard 2D full-field digital mammography (2D-FFDM) regarding the effectiveness as screening modality.

Condition or disease Intervention/treatment Phase
Breast Cancer Screening Diagnostic Test: DBT+s2D Diagnostic Test: 2D-FFDM Not Applicable

Detailed Description:
The primary objective of the study is to evaluate whether digital breast tomosynthesis plus synthesized 2D mammograms leads to a relevant increase in the detection rate of screening-detected invasive cancers compared to 2D full-field digital mammography in routine screening according to the European Guidelines. Furthermore, the incidence rate of interval cancers within a 24 months interval after screening will be compared between both study arms in order to investigate the potential for overdiagnosis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to either Digital Breast Tomosynthesis plus synthesized 2D mammograms (DBT+s2D) or 2D Full-Field Digital Mammography (2D-FFDM)
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Prospective Randomized Comparison of Digital Breast Tomosynthesis Plus Synthesized Images Versus Standard Full-field Digital Mammography in Population-based Screening (TOSYMA)
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DBT+s2D
Digital breast tomosynthesis plus synthesized 2D mammograms
Diagnostic Test: DBT+s2D
Digital breast tomosynthesis plus synthesized 2D mammograms

Active Comparator: 2D-FFDM
2D full-field digital mammography
Diagnostic Test: 2D-FFDM
2D full-field digital mammography




Primary Outcome Measures :
  1. Detection rate of invasive breast cancers [ Time Frame: Routine screening visit ]
    Number of women with screening-detected invasive breast cancer divided by the number of all women screened. A screening-detected breast cancer is classified as invasive carcinoma if the pT category (pathological tumor size) of the TNM classification falls into one of the following categories: pT1mic, pT1a, pT1b, pT1c, pT1, pT2, pT3, pT4a, pT4b, pT4c, pT4d, pT4, pTX (for evaluation purpose pTX defines histologically approved invasive breast cancer with missing tumor diameter) or the final pathological categorization has been done after neoadjuvant therapy (ypT), implying an invasive cancer prior to therapy.

  2. Cumulative 24 months incidence of interval cancers [ Time Frame: 24 months after routine screening visit ]
    The 24 months incidence of interval cancers is defined as the number of women that develop a ductal carcinoma in situ or an invasive breast cancer in the 24 months interval after a negative screening examination divided by the number of all women with a negative screening result.


Secondary Outcome Measures :
  1. Detection rate of ductal carcinoma in situ (DCIS) [ Time Frame: Routine screening visit ]
    Number of women with screening-detected ductal carcinoma in situ (if the pT category of the TNM classification falls into the category pTis) divided by the number of all women screened.

  2. Detection rate of tumor category pT1 [ Time Frame: Routine screening visit ]
    Number of women with screening-detected invasive breast cancers of the category pT1 divided by the number of all women screened. A screening-detected breast cancer is classified as breast cancer of tumor category pT1 if tumor size is ≤ 20 mm in greatest dimension and the respective pT subcategory of the pTNM classification is one of the following: pT1mic, pT1a, pT1b, pT1c, pT1.

  3. Recall rate for further assessment [ Time Frame: Routine Screening Visit ]
    Number of women with recalls for further assessment divided by the number of all women screened.

  4. Positive predictive value of recall for further assessment (PPV1) [ Time Frame: Routine screening visit ]
    Number of women with screening-detected malignancies (ductal carcinoma in situ or invasive breast cancer) divided by the number of women with recalls for further assessment.

  5. Cumulative 12 months incidence of interval cancers [ Time Frame: 12 months after routine screening visit ]
    The 12 months incidence of interval cancers is defined as the number of women that develop a ductal carcinoma in situ or an invasive breast cancer in the 12 months interval after a negative screening examination divided by the number of all women with a negative screening result.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women eligible to participate in the National Mammography Screening Program of Germany
  • Informed decision for mammography screening
  • Written informed consent

Exclusion Criteria:

  • Breast cancer up to 5 years prior to study invitation
  • Previous mammography examination < 12 months,
  • Breast implants

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): NCT03377036


Contacts
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Contact: Walter Heindel, MD, PhD +49 251 83 ext 45650 heindel@uni-muenster.de
Contact: Stefanie Weigel, MD, PhD weigels@uni-muenster.de

Locations
Show Show 21 study locations
Sponsors and Collaborators
University Hospital Muenster
German Research Foundation
Investigators
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Principal Investigator: Walter Heindel, MD, PhD Institute of Clinical Radiology University of Münster / University Hospital Münster
Additional Information:
Publications:
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Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT03377036    
Other Study ID Numbers: UKM14_0016
HE1646/5-1 ( Other Grant/Funding Number: German Research Foundation (DFG) )
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Muenster:
Breast Cancer
Population-based Screening
Digital Breast Tomosynthesis plus synthesized Mammography
Reconstructed Mammography
Full-Field Digital Mammography (FFDM)
Multicentric Randomized Controlled Trial
Diagnostic Performance
Recall Rate
Interval Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases