Screening for Breast Cancer With Digital Breast Tomosynthesis

Breast Cancer Clinical Trial

Official title:

Randomized Controlled Trial to Evaluate the Efficacy of Digital Breast Tomosynthesis in Reggio Emilia Breast Cancer Screening Program in the 45-74 Age Group

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02698202
• Other study ID #: ReTomo
• Status: Recruiting
• Phase: N/A
• First received: February 26, 2016
• Last updated: March 3, 2016
• Start date: March 2014
• Est. completion date: December 2018

Study information

• Verified date: March 2016
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Contact: Pierpaolo Pattacini, MD
• Phone: +390522296369
• Email: Pierpaolo.Pattacini[@]asmn.re.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Randomized trial comparing the performance of tomosynthesis and 2D Digital Mammography vs 2D Digital Mammography only in respect to incidence of advanced cancers (interval and following round) and interval cancers.

Description:

The investigators conduct a randomized trial (about 20000 tests in the intervention arm) comparing the performance of tomosynthesis plus 2D Digital Mammography vs usual care (2D digital mammography) in respect to incidence of advanced cancers (interval and following round) and interval cancers. The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate overdiagnosis. In Reggio Emilia a population-based screening program is active. It invites all women from 45 to 74 years old for a 2D digital mammography (2 projections, double reading) every 2 years (annually from 45 to 49).

Women will be asked for informed consent when they attend the mammography. I they accept they will be randomised to one of the two arms.

All examinations will be read by two independent radiologists, in case of discordance a third reading is asked.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40000
• Est. completion date: December 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

Inclusion Criteria:

45-70 years old women invited to breast cancer screening program who accepted to participate

Exclusion Criteria:

• previous breast cancer diagnosis

• pregnancy or suspicion of pregnancy

• presence of BRCA1/2 gene mutation

• Previous Digital Breast Tomosynthesis performed

• unable to understand informed consent

• chemotherapy in progress

• presence of breast implant

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Digital Breast Tomosynthesis
twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis

Locations

Country	Name	City	State
Italy	Azienda Sanitaria Locale Reggio Emilia	Reggio Emilia

Sponsors (3)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale Reggio Emilia	Arcispedale Santa Maria Nuova-IRCCS, Regione Emilia-Romagna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative incidence of T2+ cancers after screening		2 years	No
Primary	incidence of interval cancers		2 years	No
Secondary	Detection rate		2 years	No
Secondary	recall rate		baseline	Yes
Secondary	Positive Predictive value		baseline	Yes
Secondary	diagnostic agreement between tomosynthesis and 2d mammography		baseline	No
Secondary	Detection rate of in situ ductal carcinoma		2 years	Yes
Secondary	biopsy rate		baseline	Yes
Secondary	self-reported pain and discomfort during mammography		baseline	Yes
Secondary	x-ray dose		baseline	Yes