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Innovation in Mammography: Tomosynthesis Pathways (IMPETO)

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ClinicalTrials.gov Identifier: NCT03587259
Recruitment Status : Unknown
Verified July 2018 by Cancer Prevention and Research Institute, Italy.
Recruitment status was:  Not yet recruiting
First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Cancer Prevention and Research Institute, Italy

Study Description
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Brief Summary:

The study aims at evaluating the introduction of tomosynthesis in mammography screening, analyzing the benefits, disadvantages and feasibility in current clinical practice.

It involves women aged 45-46 that will be divided, by drawing lots, into two groups: one group will do the 2D digital mammography (control group), while the other group (intervention group) will do tomosynthesis. In the intervention group the 2D two-dimensional mammography will be reconstructed starting from tomosynthesis without exposing women to other radiation.


Condition or disease Intervention/treatment Phase
Breast Cancer Diagnostic Test: Tomosynthesis Diagnostic Test: 2D mammography Not Applicable

Detailed Description:

The IMPETO trial is a population-based, multicentre, randomised trial aimed at evaluating the clinical accuracy of Digital Breast Tomosynthesis (DBT) in adjunct to synthetic mammograms (sDM) compared to standard two-dimensional digital mammography alone (2D) in a screening programme.

45-46 year-old women resident in the screening centre catchment area of Florence and South-Est Local Health Unit are invited to attend for mammography screening and asked for informed consent to be included in the study. Women are then randomly allocated either to an usual care group (2D mammography) or to the intervention group. In the intervention group, DBT combined with sDM is proposed in order to reduce radiation exposure. The next year women of both groups will be invited to attend the usual screening examination (2D mammography). The enrolment will last 12-18 months; the whole study 36 months. The estimated sample size is 6000 women, 3000 per arm. Data will be pooled with the trial "Screening for Breast Cancer With Digital Breast Tomosynthesis", ClinicalTrials.gov Identifier: NCT02698202.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Official Title: Innovation in Mammography: Tomosynthesis Pathways
Estimated Study Start Date : September 3, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 2D mammography
45-46 years old women are invited to attend the usual screening examination (2D mammography). The next year they will be invited to make a 2D mammography, according to screening protocol.
 Diagnostic Test: 2D mammography
2D mammography is a X-ray examinations used to detect breast cancer in the screening programme.
Experimental: Tomosynthesis
45-46 years old women are invited to attend the Digital Breast Tomosynthesis (DBT) in adjunct to synthetic mammograms (sDM). The next year they will be invited to make a 2D mammography, according to screening protocol.
 Diagnostic Test: Tomosynthesis
DBT is a x-ray examination that allows to visualize the breast on 3 planes (3D) and therefore to help to see lesions hardly visible to mammography due to the overlap of glandular tissue.
Other Name: Digital Breast Tomosynthesis (DBT)


Outcome Measures
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Primary Outcome Measures :
  1. the cumulative incidence of advanced screen-detected cancers (T2 +) and the cumulative incidence of advanced interval cancers (T2 +) [ Time Frame: three years ]
    number of T2+ screen-detected cancers divided by all screened women at subsequent round of screening and number of T2+ interval cancers divided by all screened women at subsequent round of screening.


Secondary Outcome Measures :
  1. recall rate [ Time Frame: two years ]
    number of women recalled to perform 2nd level assessments) for invasive tests and for non-invasive examinations in the two arms divided by the number of screened women

  2. detection rate [ Time Frame: two years ]
    number of breast cancer cases (invasive and in situ forms) divided by the number of screened women (per 1,000)

  3. benign biopsies rate [ Time Frame: two years ]
    number of benign biopsies divided by the total number of biopsies

  4. cost analysis [ Time Frame: two years ]
    an activity based cost analysis will be performed in order to obtain the real costs of DBT screening pathway.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 46 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 45-46 years old women resident in the screening area

Exclusion Criteria:

  • previous breast cancer
  • written refusal to participate in the screening programme
  • pregnancy, breastfeeding
  • presence of prostheses;
  • ongoing chemotherapy;
  • impossibility to submit the informed consent for linguistic problems or for inability of women to provide informed consent;
  • verified presence of BRCA1 - BRCA2 (Breast Related Cancer Antigens 1 - Breast Related Cancer Antigens 2) genetic mutation or involvement in surveillance path for heredo-familial tumor;
  • previous known tomosynthesis.
Contacts and Locations
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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): NCT03587259


Contacts
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Contact: Paola Mantellini, MDr 05532697961 p.mantellini@ispro.toscana.it

Locations
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Italy
South-Est Local Health Unit
Arezzo, Italy, 52100
Contact: Roberto Turillazzi, MDr       roberto.turillazzi@uslsudest.toscana.it   
Oncological Network, Prevention and Research Institute
Florence, Italy, 50139
Contact: Paola Mantellini, MDr         
Sponsors and Collaborators
Cancer Prevention and Research Institute, Italy
Investigators
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Principal Investigator: Paola Mantellini, MDr Oncological Network, Prevention and Research Institute
More Information
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Publications:

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Responsible Party: Cancer Prevention and Research Institute, Italy
ClinicalTrials.gov Identifier: NCT03587259    
Other Study ID Numbers: F16J16000620002
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018

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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 Cancer Prevention and Research Institute, Italy:
breast cancer screening
tomosynthesis
digital mammography
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases