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Breast CancerIMPETONCT03587259

Innovation in Mammography: Tomosynthesis Pathways

A study testing Tomosynthesis and 2D mammography in people with Breast Cancer, run by Cancer Prevention and Research Institute, Italy at 2 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 45 to 46 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
Tomosynthesis and 2D mammography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,000 participants
Where
2 sitesItaly
Study dates
3 Sep 2018to 1 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 46 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Paola Mantellini, MDr contact

05532697961

p.mantellini@ispro.toscana.it

Italy2 sites

  • South-Est Local Health Unit

    Arezzo, 52100

    Roberto Turillazzi, MDr, roberto.turillazzi@uslsudest.toscana.it

  • Oncological Network, Prevention and Research Institute

    Florence, 50139

    Paola Mantellini, MDr

Other trials in Italy

About this study

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Tomosynthesis, 2D mammography
Keywords
breast cancer screening, tomosynthesis, digital mammography
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TomosynthesisDiagnostic test

    Also called Digital Breast Tomosynthesis (DBT)

    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.

  • 2D mammographyDiagnostic test

    2D mammography is a X-ray examinations used to detect breast cancer in the screening programme.

Study groups in NCT03587259
Study groupRoleWhat they receive
2D mammographyActive comparator45-46 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.
Receives: Diagnostic Test: 2D mammography
TomosynthesisExperimental45-46 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.
Receives: Diagnostic Test: Tomosynthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the cumulative incidence of advanced screen-detected cancers (T2 +) and the cumulative incidence of advanced interval cancers (T2 +)

    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.

    Measured: three years

Secondary outcomes (4)

  1. recall rate

    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

    Measured: two years

  2. detection rate

    number of breast cancer cases (invasive and in situ forms) divided by the number of screened women (per 1,000)

    Measured: two years

  3. benign biopsies rate

    number of benign biopsies divided by the total number of biopsies

    Measured: two years

  4. cost analysis

    an activity based cost analysis will be performed in order to obtain the real costs of DBT screening pathway.

    Measured: two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2018
  2. Study start3 Sep 2018 (estimated)
  3. Primary completion1 Sep 2020 (estimated)
  4. Study completion1 Sep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
6,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03587259
Sponsor's protocol ID
F16J16000620002
Acronym
IMPETO
Status last verified
Jul 2018
First submitted
27 Jun 2018
Last updated
16 Jul 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ciatto S, Houssami N, Bernardi D, Caumo F, Pellegrini M, Brunelli S, Tuttobene P, Bricolo P, Fanto C, Valentini M, Montemezzi S, Macaskill P. Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study. Lancet Oncol. 2013 Jun;14(7):583-9. doi: 10.1016/S1470-2045(13)70134-7. Epub 2013 Apr 25.

    PubMed 23623721

  • Skaane P, Bandos AI, Gullien R, Eben EB, Ekseth U, Haakenaasen U, Izadi M, Jebsen IN, Jahr G, Krager M, Niklason LT, Hofvind S, Gur D. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology. 2013 Apr;267(1):47-56. doi: 10.1148/radiol.12121373. Epub 2013 Jan 7.

    PubMed 23297332

  • Gilbert FJ, Tucker L, Gillan MG, Willsher P, Cooke J, Duncan KA, Michell MJ, Dobson HM, Lim YY, Purushothaman H, Strudley C, Astley SM, Morrish O, Young KC, Duffy SW. The TOMMY trial: a comparison of TOMosynthesis with digital MammographY in the UK NHS Breast Screening Programme--a multicentre retrospective reading study comparing the diagnostic performance of digital breast tomosynthesis and digital mammography with digital mammography alone. Health Technol Assess. 2015 Jan;19(4):i-xxv, 1-136. doi: 10.3310/hta19040.

    PubMed 25599513

  • Skaane P, Bandos AI, Eben EB, Jebsen IN, Krager M, Haakenaasen U, Ekseth U, Izadi M, Hofvind S, Gullien R. Two-view digital breast tomosynthesis screening with synthetically reconstructed projection images: comparison with digital breast tomosynthesis with full-field digital mammographic images. Radiology. 2014 Jun;271(3):655-63. doi: 10.1148/radiol.13131391. Epub 2014 Jan 24.

    PubMed 24484063

  • Paci E, Mantellini P, Giorgi Rossi P, Falini P, Puliti D; TBST Working Group. [Tailored Breast Screening Trial (TBST)]. Epidemiol Prev. 2013 Jul-Oct;37(4-5):317-27. Italian.

    PubMed 24293498

  • McDonald ES, McCarthy AM, Akhtar AL, Synnestvedt MB, Schnall M, Conant EF. Baseline Screening Mammography: Performance of Full-Field Digital Mammography Versus Digital Breast Tomosynthesis. AJR Am J Roentgenol. 2015 Nov;205(5):1143-8. doi: 10.2214/AJR.15.14406.

    PubMed 26496565

  • Bernardi D, Ciatto S, Pellegrini M, Anesi V, Burlon S, Cauli E, Depaoli M, Larentis L, Malesani V, Targa L, Baldo P, Houssami N. Application of breast tomosynthesis in screening: incremental effect on mammography acquisition and reading time. Br J Radiol. 2012 Dec;85(1020):e1174-8. doi: 10.1259/bjr/19385909.

    PubMed 23175484

  • Bernardi D, Belli P, Benelli E, Brancato B, Bucchi L, Calabrese M, Carbonaro LA, Caumo F, Cavallo-Marincola B, Clauser P, Fedato C, Frigerio A, Galli V, Giordano L, Giorgi Rossi P, Golinelli P, Morrone D, Mariscotti G, Martincich L, Montemezzi S, Naldoni C, Paduos A, Panizza P, Pediconi F, Querci F, Rizzo A, Saguatti G, Tagliafico A, Trimboli RM, Zappa M, Zuiani C, Sardanelli F. Digital breast tomosynthesis (DBT): recommendations from the Italian College of Breast Radiologists (ICBR) by the Italian Society of Medical Radiology (SIRM) and the Italian Group for Mammography Screening (GISMa). Radiol Med. 2017 Oct;122(10):723-730. doi: 10.1007/s11547-017-0769-z. Epub 2017 May 25.

    PubMed 28540564

  • Lang K, Andersson I, Rosso A, Tingberg A, Timberg P, Zackrisson S. Performance of one-view breast tomosynthesis as a stand-alone breast cancer screening modality: results from the Malmo Breast Tomosynthesis Screening Trial, a population-based study. Eur Radiol. 2016 Jan;26(1):184-90. doi: 10.1007/s00330-015-3803-3. Epub 2015 May 1.

    PubMed 25929946

  • Lang K, Nergarden M, Andersson I, Rosso A, Zackrisson S. False positives in breast cancer screening with one-view breast tomosynthesis: An analysis of findings leading to recall, work-up and biopsy rates in the Malmo Breast Tomosynthesis Screening Trial. Eur Radiol. 2016 Nov;26(11):3899-3907. doi: 10.1007/s00330-016-4265-y. Epub 2016 Mar 4.

    PubMed 26943342

Questions about this trial

What is this clinical trial studying?

A study testing Tomosynthesis and 2D mammography in people with Breast Cancer, run by Cancer Prevention and Research Institute, Italy at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Paola Mantellini, MDr (05532697961, p.mantellini@ispro.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the cumulative incidence of advanced screen-detected cancers (T2 +) and the cumulative incidence of advanced interval cancers (T2 +) (time frame: three years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03587259, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.

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Innovation in Mammography: Tomosynthesis Pathways | AzTrials