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Low Dose Tomosynthesis Compared to Traditional Tomosynthesis

Primary Purpose

Breast Neoplasms

Status

Terminated

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Tomo Assessment

About this trial

This is an interventional diagnostic trial for Breast Neoplasms

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Ospedale San Rafaele

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tomo Assessment

Arm Description

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

Outcomes

Primary Outcome Measures

X-ray dose

X-ray dose will be measured per projection.

Secondary Outcome Measures

Lesion conspicuity comparison of images from study device vs comparator

Lesion conspicuity will be assessed by image readers (radiologists) comparing the conspicuity of the same lesion imaged with the study device to the comparator

Full Information

NCT ID

NCT02771444

First Posted

May 10, 2016

Last Updated

March 22, 2018

Sponsor

Philips Digital Mammography Sweden AB

1. Study Identification

Unique Protocol Identification Number

NCT02771444

Brief Title

Low Dose Tomosynthesis Compared to Traditional Tomosynthesis

Official Title

Low Dose Tomosynthesis Compared to Traditional Tomosynthesis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Terminated

Why Stopped

Decision by sponsor, development stopped.

Study Start Date

December 2016 (Actual)

Primary Completion Date

March 22, 2018 (Actual)

Study Completion Date

March 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Philips Digital Mammography Sweden AB

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Tomosynthesis is a relatively new technology to acquire mammographic images where images are acquired over several projection angles, giving 3d information that can help radiologists assess images. The aim of the study is to see whether a new low-dose tomosynthesis system has comparable image quality at a lower x-ray radiation dose to a comparator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasms

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

This is an imaging study. All participants will be imaged using two modalities. All participant data will be deidentified.

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tomo Assessment

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Tomo Assessment

Other Intervention Name(s)

MicroDose Tomosynthesis

Intervention Description

A four-view tomosynthesis examination

Primary Outcome Measure Information:

Title

X-ray dose

Description

X-ray dose will be measured per projection.

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Lesion conspicuity comparison of images from study device vs comparator

Description

Lesion conspicuity will be assessed by image readers (radiologists) comparing the conspicuity of the same lesion imaged with the study device to the comparator

Time Frame

4 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Woman over 40 years of age Has a tomosynthesis examination with comparator Has a mammographic finding Exclusion Criteria: Pregnant, breastfeeding or believes she may be pregnant Unable or unwilling to give informed consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pietro Panizza, M.D

Organizational Affiliation

Ospedale San Raffaele

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ospedale San Rafaele

City

Milan

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

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Low Dose Tomosynthesis Compared to Traditional Tomosynthesis

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