Tomosymthesis for Breast Mass Lesion Characterization

Female Breast Cancer Clinical Trial

— DBT  

Official title:

Diagnostic Value of Digital Breast Tomosymthesis for Breast Mass Lesions Characterization

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04863833
• Other study ID #: Tomosymthesis
• Status: Not yet recruiting
• Start date: September 1, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: April 2021
• Source: Assiut University
• Contact: Asmaa Abdelmonem
• Phone: +201123153571
• Email: asmaaelshahaby[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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,.)

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Female Breast Cancer

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Asmaa Abdelmonem Ahmed	Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnosis of breast mass lesions	Mass regular in shape or not, homogeneous in echogenicity or not,calicfied or not,has speculation or not,single or multiple	2 years
Secondary	characters of benign and malignant breast mass	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	2 years