NCT02771444

Brief Summary

This study aims to evaluate image quality of a low-dose tomosynthesis system versus a comparator. Subjects will undergo a four-view tomosynthesis examination with the comparator and with the study device, and images will be assessed by several radiologists by comparing details in the images from the two systems.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2018

Completed
Last Updated

March 26, 2018

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

May 10, 2016

Last Update Submit

March 22, 2018

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • X-ray dose

    X-ray dose will be measured per projection.

    4 months

Secondary Outcomes (1)

  • Lesion conspicuity comparison of images from study device vs comparator

    4 months

Study Arms (1)

Tomo Assessment

EXPERIMENTAL

Subjects will have a 4-view tomosynthesis examination with the study device.

Device: Tomo Assessment

Interventions

Tomo AssessmentDEVICE

A four-view tomosynthesis examination

Also known as: MicroDose Tomosynthesis
Tomo Assessment

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman over 40 years of age
  • Has a tomosynthesis examination with comparator
  • Has a mammographic finding

You may not qualify if:

  • Pregnant, breastfeeding or believes she may be pregnant
  • Unable or unwilling to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Rafaele

Milan, Italy

Location

Related Publications (1)

  • Venturini E, Losio C, Rodighiero M, Ferrarese G, Del Vecchio A, Loria A, Rehn JR, Panizza P. Low dose photon-counting digital breast tomosynthesis: comparison with a commercially available tomosynthesis unit in the detection and characterization of breast carcinomas. Radiol Med. 2025 Oct 4. doi: 10.1007/s11547-025-02115-7. Online ahead of print.

    PMID: 41045355DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Pietro Panizza, M.D

    Ospedale San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
This is an imaging study. All participants will be imaged using two modalities. All participant data will be deidentified.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 13, 2016

Study Start

December 1, 2016

Primary Completion

March 22, 2018

Study Completion

March 22, 2018

Last Updated

March 26, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)