Innovation in Mammography: Tomosynthesis Pathways (IMPETO)

July 13, 2018 updated by: Cancer Prevention and Research Institute, Italy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

6000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Arezzo, Italy, 52100
      • Florence, Italy, 50139
        • Oncological Network, Prevention and Research Institute
        • Contact:
          • Paola Mantellini, MDr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 46 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Digital Breast Tomosynthesis (DBT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
two years
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)
two years
benign biopsies rate
Time Frame: two years
number of benign biopsies divided by the total number of biopsies
two years
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.
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Prevention and Research Institute, Italy

Investigators

  • Principal Investigator: Paola Mantellini, MDr, Oncological Network, Prevention and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 3, 2018

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

June 27, 2018

First Submitted That Met QC Criteria

July 13, 2018

First Posted (Actual)

July 16, 2018

Study Record Updates

Last Update Posted (Actual)

July 16, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F16J16000620002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on 2D mammography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe