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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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Vienna, Oostenrijk, A-1090
- Werving
- Medical University of Vienna
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Contact:
- Thomas Moritz, MD
- Telefoonnummer: 4818 +43140400
- E-mail: thomas.moritz@meduniwien.ac.at
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Vienna, Oostenrijk, A-1100
- Werving
- Kaiser Franz Josef Spital
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Contact:
- Gabrielle Kienzer, MD
- Telefoonnummer: 3608 +43160191
- E-mail: Gabrielle.kienzer@wienkav.at
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Vienna, Oostenrijk, A-1140
- Werving
- Hanusch Krankenhaus
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Contact:
- Reinhard Bernt, MD
- Telefoonnummer: 86630 +43191021
- E-mail: reinhard.bernt@wgkk.at
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Styria
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Graz, Styria, Oostenrijk, A-8036
- Werving
- Medical University of Graz
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Contact:
- Sabine Oswald, MD
- Telefoonnummer: 13850 +43 316385
- E-mail: sabine.oswald@klinikum-graz.at
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Upper Austria
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Wels, Upper Austria, Oostenrijk, A-4600
- Werving
- Klinikum Wels-Grieskirchen
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Contact:
- Stefan Meindl, MD
- Telefoonnummer: 2413 +437242415
- E-mail: stefan.meindl@klinikum-wegr.at
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions
Tijdsspanne: One year
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One year
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Sensitivity of Digital Breast Tomosynthesis in the detection of malignant breast lesions
Tijdsspanne: One year
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One year
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Thomas Moritz, MD, Medical University of Vienna
- Studie directeur: Thomas Helbich, MD Prof. MBA MSc, Medical University of Vienna
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TomoTrial001
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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