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Trial record 2 of 881 for:    EMILIA

Screening for Breast Cancer With Digital Breast Tomosynthesis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Azienda Unità Sanitaria Locale Reggio Emilia
Sponsor:
Collaborators:
Arcispedale Santa Maria Nuova-IRCCS
Regione Emilia-Romagna
Information provided by (Responsible Party):
Azienda Unità Sanitaria Locale Reggio Emilia
ClinicalTrials.gov Identifier:
NCT02698202
First received: February 26, 2016
Last updated: March 3, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Breast Cancer
Device: Digital Breast Tomosynthesis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
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

Resource links provided by NLM:


Further study details as provided by Azienda Unità Sanitaria Locale Reggio Emilia:

Primary Outcome Measures:
  • cumulative incidence of T2+ cancers after screening [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • incidence of interval cancers [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Detection rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • recall rate [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • Positive Predictive value [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • diagnostic agreement between tomosynthesis and 2d mammography [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Detection rate of in situ ductal carcinoma [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • biopsy rate [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • self-reported pain and discomfort during mammography [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • x-ray dose [ Time Frame: baseline ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40000
Study Start Date: March 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Digital Breast Tomosynthesis
to the experimental arm will be offered twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis
Device: Digital Breast Tomosynthesis
twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis
No Intervention: standard mammography
to the control arm the usual 2D standard mammography exam will be offered

Detailed 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.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02698202

Contacts
Contact: Pierpaolo Pattacini, MD +390522296369 Pierpaolo.Pattacini@asmn.re.it

Locations
Italy
Azienda Sanitaria Locale Reggio Emilia Recruiting
Reggio Emilia, Italy
Sub-Investigator: Luisa Paterlini         
Sponsors and Collaborators
Azienda Unità Sanitaria Locale Reggio Emilia
Arcispedale Santa Maria Nuova-IRCCS
Regione Emilia-Romagna
Investigators
Principal Investigator: Pierpaolo Pattacini, MD Inter-Institutional Imaging Department, IRCCS-Arcispedale Santa Maria Nuova, Viale Umberto I 50, 42123, Reggio Emilia, Italy
  More Information

Responsible Party: Azienda Unità Sanitaria Locale Reggio Emilia
ClinicalTrials.gov Identifier: NCT02698202     History of Changes
Other Study ID Numbers: ReTomo 
Study First Received: February 26, 2016
Last Updated: March 3, 2016
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Unità Sanitaria Locale Reggio Emilia:
Tomosynthesis,sensitivity,specificity,screening,mammography

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on December 09, 2016