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NCT03288792

A Evaluation of 3D Functional MIRA System in Women With Mammographically Dense Breasts

Terminated NA Last updated 3 May 2019
What this trial tests

NA trial testing RI8 device imaging in Breast Cancer in 435 participants. Terminated before completion.

Timeline
15 April 2018
Primary endpoint
9 April 2019
30 April 2019

Quick facts

Lead sponsorReal Imaging Ltd.
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposescreening
Enrollment435
Start date15 April 2018
Primary completion9 April 2019
Estimated completion30 April 2019
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Real Imaging Ltd.

Who can join

Adults 40 to 70, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this image acquisition study is to compare, in a Reader Study, the RI8 system used in conjunction with a conventional mammography to mammography alone, and to determine whether the addition of supplementary RI8 result will improve ROC area under the curve. The study is prospective, multi-center, sequential, control trial with the woman serving as her own control. Women determined to have heterogeneously or extremely dense breast based on her previous mammogram and are undergoing routine screening mammography at one of the clinical sites assigned for this study will be eligible to join the study.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03288792.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing