DBT: Tomosymthesis for Breast Mass Lesion Characterization

Sponsor
Asmaa Abdelmonem Ahmed (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04863833
Collaborator
Assiut University (Other)
30
25

Study Details

Study Description

Brief Summary

To Estimate diagnostic value of tomo synthesis for breast mass lesions characterization ( shape, margin, and density, detail of mass margins, Differences in mass density , Tumor measurement,.)

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Breast lesions are observed in about 20% of female patients1. However this percentage is likely to represent an underestimation of the true incidence of these lesions because breast imaging (MRI, ultrasound or mammography) was performed in only a small number of the patients of these series. The lesions are possibly palpable and most of the time asymptomatic2.

    In current clinical practice, mammography is the standard imaging modality for breast cancer screening and diagnosis.3 The advantages of mammography include a reasonably high sensitivity, high resolution, and low patient dose. However, a mammogram still suffers from being a two-dimensional projection of a three-dimensional object. The resulting overlap of normal fibro glandular tissue cannot only obscure the detection and characterization of lesions but also present false alarms leading to unnecessary recall studies.4-6 To address this key limitation of mammography, 3D x-ray imaging techniques have been developed, including dedicated breast computed tomography (CT), which takes cone-beam x-ray projection images of the uncompressed breast in a full 360° scan, thus enabling reconstruction of a 3D breast volume 6-10 Digital x-ray tomosynthesis11,12(often abbreviated as "tomo") for the breast is a form of limited-angle cone-beam CT.13-14 A restricted number of projection images are acquired in an arc in the conventional mammography projection geometry, while the breast is compressed adjacent to the detector. Although some information is lost due to angular under sampling, breast tomo still creates a 3D volume at a dose comparable to that of traditional mammography. Moreover, the tomo device itself is usually based on an existing full-field digital mammography (FFDM) system. Although compression is required, this ensures proper posterior tissue coverage, immobilization to minimize motion artifacts, and a low dose.15The similarity of tomo to FFDM in terms of patient positioning, image acquisition, and aspects of image display suggests that there is minimal retraining required for the technologist or radiologist.16 As such, breast tomo synthesis is a 3D breast imaging modality with the potential to replace mammography17

    . DBT offers potential advantages for evaluating masses, areas of architectural distortion, and asymmetries compared with those of conventional 2D mammographic images 18 In diagnostic settings, DBT improves work-up efficiency and the selection of patients recommended for biopsy, thereby reducing associated costs and additional imaging studies including additional mammographic views and unnecessary biopsies 19

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Diagnostic Value of Digital Breast Tomosymthesis for Breast Mass Lesions Characterization
    Anticipated Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. diagnosis of breast mass lesions [2 years]

      Mass regular in shape or not, homogeneous in echogenicity or not,calicfied or not,has speculation or not,single or multiple

    Secondary Outcome Measures

    1. characters of benign and malignant breast mass [2 years]

      Mass invasive to all breast layer or not ,sarcoma,carcinoma or lymphoma,lymph node metastasis or not, secondary metastasis or not ,staging byTNM score, treatment by radical mastectomy or conservative mastectomy, distracted shape of breast or not

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    female patients who undergoes DBT must have a compressed breast thickness of more than 2 cm,with small mass,age>35,not have mastitis,not proceed breast implant

    Exclusion Criteria:
    • Female Patients with breast implant ,severe nipple discharge, large palpable mass, mastitis and women within reproductive age(15-35 ) Female patients with huge breast that may exceed the detector size requirements for global diagnostic DBT.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Asmaa Abdelmonem Ahmed
    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Asmaa Abdelmonem Ahmed, Assistant Lecturer, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04863833
    Other Study ID Numbers:
    • Tomosymthesis
    First Posted:
    Apr 28, 2021
    Last Update Posted:
    Apr 28, 2021
    Last Verified:
    Apr 1, 2021
    Keywords provided by Asmaa Abdelmonem Ahmed, Assistant Lecturer, Assiut University

    Study Results

    No Results Posted as of Apr 28, 2021