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Screening for Breast Cancer With Digital Breast Tomosynthesis

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ClinicalTrials.gov Identifier: NCT02698202
Recruitment Status : Unknown
Verified March 2016 by Azienda Unità Sanitaria Locale Reggio Emilia.
Recruitment status was:  Recruiting
First Posted : March 3, 2016
Last Update Posted : March 4, 2016
Sponsor:
Collaborators:
Arcispedale Santa Maria Nuova-IRCCS
Regione Emilia-Romagna
Information provided by (Responsible Party):
Azienda Unità Sanitaria Locale Reggio Emilia

Tracking Information
First Submitted Date  ICMJE February 26, 2016
First Posted Date  ICMJE March 3, 2016
Last Update Posted Date March 4, 2016
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2016)
  • cumulative incidence of T2+ cancers after screening [ Time Frame: 2 years ]
  • incidence of interval cancers [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2016)
  • Detection rate [ Time Frame: 2 years ]
  • recall rate [ Time Frame: baseline ]
  • Positive Predictive value [ Time Frame: baseline ]
  • diagnostic agreement between tomosynthesis and 2d mammography [ Time Frame: baseline ]
  • Detection rate of in situ ductal carcinoma [ Time Frame: 2 years ]
  • biopsy rate [ Time Frame: baseline ]
  • self-reported pain and discomfort during mammography [ Time Frame: baseline ]
  • x-ray dose [ Time Frame: baseline ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Screening for Breast Cancer With Digital Breast Tomosynthesis
Official Title  ICMJE Randomized Controlled Trial to Evaluate the Efficacy of Digital Breast Tomosynthesis in Reggio Emilia Breast Cancer Screening Program in the 45-74 Age Group
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Breast Cancer
Intervention  ICMJE Device: Digital Breast Tomosynthesis
twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis
Study Arms  ICMJE
  • Experimental: Digital Breast Tomosynthesis
    to the experimental arm will be offered twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis
    Intervention: Device: Digital Breast Tomosynthesis
  • No Intervention: standard mammography
    to the control arm the usual 2D standard mammography exam will be offered
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 26, 2016)
40000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02698202
Other Study ID Numbers  ICMJE ReTomo
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Azienda Unità Sanitaria Locale Reggio Emilia
Study Sponsor  ICMJE Azienda Unità Sanitaria Locale Reggio Emilia
Collaborators  ICMJE
  • Arcispedale Santa Maria Nuova-IRCCS
  • Regione Emilia-Romagna
Investigators  ICMJE
Principal Investigator: Pierpaolo Pattacini, MD Inter-Institutional Imaging Department, IRCCS-Arcispedale Santa Maria Nuova, Viale Umberto I 50, 42123, Reggio Emilia, Italy
PRS Account Azienda Unità Sanitaria Locale Reggio Emilia
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP