Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT07114679

Noch nicht rekrutierend

MBI-GB-Pilot: Molecular Breast Imaging (MBI)-Guided Biopsy

Interventionsstudie

Phase nicht angegeben

University of Texas Southwestern Medical Center

Sponsor: Smart Breast Corp.

Zuletzt aktualisiert: 11. August 2025

Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.

The goal of this pilot clinical trial is to demonstrate supplemental screening MBI (molecular breast imaging) in women with dense breasts. The main questions it aims to answer are:

* Does screening MBI find more cancer than screening DBT (3D mammography, digital breast tomosynthesis?
* Does screening MBI result in more call-backs for biopsy than DBT?
* How well does MBI-guided biopsy conform with pathology reports?

Researchers will compare screening MBI to screening DBT to see if MBI is more sensitive to detecting cancer in women with dense breasts.

Participants will

* Receive both screening DBT and screening MBI
* Receive either DBT-guided or MBI-guided biopsy (randomly assigned), if required by the screening images

Detaillierte Beschreibung anzeigen

Behandlungskategorie

Gerät

Erforderliche Mutationen

Keine

Studie gestartet

12. Juni 2027

Zuletzt vom Sponsor aktualisiert

11. August 2025

Voraussichtlicher Abschluss

1. Februar 2028

Studienkontakt

Name:James W Hugg, PhD

E-Mail:James.Hugg@SmartBreast.com

Telefon:724-584-3266

Name:Bradley E Patt, PhD

E-Mail:Brad.Patt@SmartBreast.com

Telefon:818-645-4081

Eignung

Einschlusskriterien

* dense breasts (BI-RADS C or D) on screening DBT

Ausschlusskriterien

* pregnancy

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Design-Details

ZuteilungN/A

InterventionsmodellSingle Group Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer250

Arme & Interventionen

Arme

Interventionen

Typ: Active Comparator

Beschreibung: Screening DBT and screening MBI are compared in women with dense breasts. Then, DBT-guided biopsy and MBI-guided biopsy are compared.

Interventionen:

Molecular Breast Imaging
MBI-guided biopsy

Ergebnismessungen

Primäre Ergebnismessungen

Cancer Detection Rateless than one day

The number of cancers found by a particular modality compared to the number of women with dense breasts screened by that modality.

Sekundäre Ergebnismessungen

Concordance Rateless than a day

MBI-guided biopsies include an MBI image of the biopsy tissue samples in a Petri dish. Comparison of that image with the pathology report yields concordance.

Biopsy Call-Back Rateless than a day

The percentage of women with dense breasts screened by a particular modality who have a suspicious lesion on their screening and they require biopsy.

Duration of Biopsyless than a day

The amount of time that the modality-guided biopsy took to complete.

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Studienzentren

University of Texas Southwestern Medical Center

Dallas, Texas, US

Name:Radiology Clinical Research Manager

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