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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Vienna, Østerrike, A-1090
- Rekruttering
- Medical University of Vienna
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Ta kontakt med:
- Thomas Moritz, MD
- Telefonnummer: 4818 +43140400
- E-post: thomas.moritz@meduniwien.ac.at
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Vienna, Østerrike, A-1100
- Rekruttering
- Kaiser Franz Josef Spital
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Ta kontakt med:
- Gabrielle Kienzer, MD
- Telefonnummer: 3608 +43160191
- E-post: Gabrielle.kienzer@wienkav.at
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Vienna, Østerrike, A-1140
- Rekruttering
- Hanusch Krankenhaus
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Ta kontakt med:
- Reinhard Bernt, MD
- Telefonnummer: 86630 +43191021
- E-post: reinhard.bernt@wgkk.at
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Styria
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Graz, Styria, Østerrike, A-8036
- Rekruttering
- Medical University of Graz
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Ta kontakt med:
- Sabine Oswald, MD
- Telefonnummer: 13850 +43 316385
- E-post: sabine.oswald@klinikum-graz.at
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Upper Austria
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Wels, Upper Austria, Østerrike, A-4600
- Rekruttering
- Klinikum Wels-Grieskirchen
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Ta kontakt med:
- Stefan Meindl, MD
- Telefonnummer: 2413 +437242415
- E-post: stefan.meindl@klinikum-wegr.at
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions
Tidsramme: One year
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One year
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Sensitivity of Digital Breast Tomosynthesis in the detection of malignant breast lesions
Tidsramme: One year
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One year
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Thomas Moritz, MD, Medical University of Vienna
- Studieleder: Thomas Helbich, MD Prof. MBA MSc, Medical University of Vienna
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TomoTrial001
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