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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

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Digital Breast Tomosynthesis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. cumulative incidence of T2+ cancers after screening [ Time Frame: 2 years ]
  2. incidence of interval cancers [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Detection rate [ Time Frame: 2 years ]
  2. recall rate [ Time Frame: baseline ]
  3. Positive Predictive value [ Time Frame: baseline ]
  4. diagnostic agreement between tomosynthesis and 2d mammography [ Time Frame: baseline ]
  5. Detection rate of in situ ductal carcinoma [ Time Frame: 2 years ]
  6. biopsy rate [ Time Frame: baseline ]
  7. self-reported pain and discomfort during mammography [ Time Frame: baseline ]
  8. x-ray dose [ Time Frame: baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698202


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

Locations
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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
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Principal Investigator: Pierpaolo Pattacini, MD Inter-Institutional Imaging Department, IRCCS-Arcispedale Santa Maria Nuova, Viale Umberto I 50, 42123, Reggio Emilia, Italy
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Responsible Party: Azienda Unità Sanitaria Locale Reggio Emilia
ClinicalTrials.gov Identifier: NCT02698202    
Other Study ID Numbers: ReTomo
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016
Keywords provided by Azienda Unità Sanitaria Locale Reggio Emilia:
Tomosynthesis,sensitivity,specificity,screening,mammography
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases