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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Vienna, 오스트리아, A-1090
- 모병
- Medical University of Vienna
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연락하다:
- Thomas Moritz, MD
- 전화번호: 4818 +43140400
- 이메일: thomas.moritz@meduniwien.ac.at
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Vienna, 오스트리아, A-1100
- 모병
- Kaiser Franz Josef Spital
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연락하다:
- Gabrielle Kienzer, MD
- 전화번호: 3608 +43160191
- 이메일: Gabrielle.kienzer@wienkav.at
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Vienna, 오스트리아, A-1140
- 모병
- Hanusch Krankenhaus
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연락하다:
- Reinhard Bernt, MD
- 전화번호: 86630 +43191021
- 이메일: reinhard.bernt@wgkk.at
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Styria
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Graz, Styria, 오스트리아, A-8036
- 모병
- Medical University of Graz
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연락하다:
- Sabine Oswald, MD
- 전화번호: 13850 +43 316385
- 이메일: sabine.oswald@klinikum-graz.at
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Upper Austria
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Wels, Upper Austria, 오스트리아, A-4600
- 모병
- Klinikum Wels-Grieskirchen
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연락하다:
- Stefan Meindl, MD
- 전화번호: 2413 +437242415
- 이메일: stefan.meindl@klinikum-wegr.at
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions
기간: One year
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One year
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2차 결과 측정
결과 측정 |
기간 |
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Sensitivity of Digital Breast Tomosynthesis in the detection of malignant breast lesions
기간: One year
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One year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Thomas Moritz, MD, Medical University of Vienna
- 연구 책임자: Thomas Helbich, MD Prof. MBA MSc, Medical University of Vienna
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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