Innovation in Mammography: Tomosynthesis Pathways

Breast Cancer Clinical Trial

— IMPETO  

Official title:

Innovation in Mammography: Tomosynthesis Pathways

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03587259
• Other study ID #: F16J16000620002
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: July 2018
• Source: Cancer Prevention and Research Institute, Italy
• Contact: Paola Mantellini, MDr
• Phone: 05532697961
• Email: p.mantellini[@]ispro.toscana.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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), 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6000
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 46 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Locations

Country	Name	City	State
Italy	South-Est Local Health Unit	Arezzo
Italy	Oncological Network, Prevention and Research Institute	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Prevention and Research Institute, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (10)

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. — View Citation

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. — View Citation

Ciatto S, Houssami N, Bernardi D, Caumo F, Pellegrini M, Brunelli S, Tuttobene P, Bricolo P, Fantò 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. — View Citation

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. — View Citation

Lång 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 Malmö 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. — View Citation

Lång K, Nergården 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 Malmö Breast Tomosynthesis Screening Trial. Eur Radiol. 2016 Nov;26(11):3899-3907. Epub 2016 Mar 4. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	three years
Secondary	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	two years
Secondary	detection rate	number of breast cancer cases (invasive and in situ forms) divided by the number of screened women (per 1,000)	two years
Secondary	benign biopsies rate	number of benign biopsies divided by the total number of biopsies	two years
Secondary	cost analysis	an activity based cost analysis will be performed in order to obtain the real costs of DBT screening pathway.	two years