- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01524029
Digital Breast Tomosynthesis Versus Digital Mammography: A National Multicenter Trial
Digital Breast Tomosynthesis vs. Digital Mammography: A National Multicenter Trial
The goal of this study is to determine the value of the new mammography technique called Digital Breast Tomosynthesis (DBT) compared to the current standard technique Digital Mammography for the early detection of Breast Cancer.
DBT is able to compute a three-dimensional image of a breast from several low-dose mammographies taken from different angles while the device is moving around the breast in a circular motion. This should overcome a significant limitation of Digital Mammography arising from the masking of breast cancer in a mammography image caused by overlying normal breast tissue.
This is a study conducted in several Austrian Breast Imaging Centers.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
This prospective national multicenter multivendor trial aims at determining the impact of the novel technique Digital Breast Tomosynthesis (DBT) in the assessment and screening for breast cancer. Mammography is the primary imaging modality for the early detection of clinically occult breast cancer.
Despite advances in mammographic technique, mammography is still limited with regard to both sensitivity and specificity. In the majority of cases these limitations arise from the masking of subtle breast cancer lesions by overlapping breast tissue.
DBT is a novel technique that tries to overcome these limitations by performing a 3D-reconstruction of breast tissue from multiple low-dose digital mammographic images acquired in several planes in a 15 to 50 degree angle.
Early studies indicate an advantage of DBT compared to the standard Full Field Digital Mammography (FFDM) in terms of an improvement of specificity without cutback in sensitivity.
Controversy continues over the use of DBT in combination with FFDM or as a standalone screening method without concomitant 2D imaging. Unfortunately, the peer-reviewed publications evaluating DBT are limited and consist of single institution studies with a small number of participants.
The purpose of this study is to evaluate the novel technique of DBT compared to routine FFDM in a clinical large sample study (600 participants) to provide the path to implementation of this new technique into clinical and screening routine.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Vienna, Austria, A-1090
- Reclutamento
- Medical University of Vienna
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Contatto:
- Thomas Moritz, MD
- Numero di telefono: 4818 +43140400
- Email: thomas.moritz@meduniwien.ac.at
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Vienna, Austria, A-1100
- Reclutamento
- Kaiser Franz Josef Spital
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Contatto:
- Gabrielle Kienzer, MD
- Numero di telefono: 3608 +43160191
- Email: Gabrielle.kienzer@wienkav.at
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Vienna, Austria, A-1140
- Reclutamento
- Hanusch Krankenhaus
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Contatto:
- Reinhard Bernt, MD
- Numero di telefono: 86630 +43191021
- Email: reinhard.bernt@wgkk.at
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Styria
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Graz, Styria, Austria, A-8036
- Reclutamento
- Medical University of Graz
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Contatto:
- Sabine Oswald, MD
- Numero di telefono: 13850 +43 316385
- Email: sabine.oswald@klinikum-graz.at
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Upper Austria
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Wels, Upper Austria, Austria, A-4600
- Reclutamento
- Klinikum Wels-Grieskirchen
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Contatto:
- Stefan Meindl, MD
- Numero di telefono: 2413 +437242415
- Email: stefan.meindl@klinikum-wegr.at
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
The study population consists of two groups:
One screening group consisting of asymptomatic women (Age 40+) referred for a screening mammography examination.
The second group consists of women aged 25+ referred for further examination of a breast lesion.
Descrizione
Inclusion Criteria:
- Age > 25 years (40 years or older for Screening Cohort)
- No history of breast cancer
- Written informed consent
- Asymptomatic women in follow up for early detection of breast cancer or
- Patients with a recent positive mammography (BI-RADS 3-5)
Exclusion Criteria:
- Pregnant and breast feeding women
- Unable to tolerate breast compression
- Breast implants
- Unable to understand or execute written informed consent
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Breast Cancer Screening Patients
Group 1 consists of Women referred to Breast Cancer Screening examinations at a participating Austrian Breast Imaging Site
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Diagnostic Patients
Patients referred to a participating Breast Imaging Center for a clinically or radiologically detected breast lesion
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions
Lasso di tempo: One year
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One year
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Sensitivity of Digital Breast Tomosynthesis in the detection of malignant breast lesions
Lasso di tempo: One year
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One year
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Thomas Moritz, MD, Medical University of Vienna
- Direttore dello studio: Thomas Helbich, MD Prof. MBA MSc, Medical University of Vienna
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TomoTrial001
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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