Tomosymthesis for Breast Mass Lesion Characterization (DBT)

• ClinicalTrials.gov Identifier: NCT04863833
• Recruitment Status: Not yet recruiting
• First Posted: April 28, 2021
• Last Update Posted: April 28, 2021
• Sponsor: Asmaa Abdelmonem Ahmed
• Collaborator: Assiut University
• Information provided by (Responsible Party): Asmaa Abdelmonem Ahmed, Assiut University

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
Female Breast Cancer

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

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. diagnosis of breast mass lesions [ Time Frame: 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 [ Time Frame: 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

• Ages Eligible for Study: 35 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Self representative of gender identity
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

All female patients except mentioned in exclusion criteria

. Female patients who undergoes DBT must have a compressed breast thickness of more than 2 cm; therefore, some patients will not qualify

Criteria

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

Contacts

Contact: Asmaa Abdelmonem; +201123153571; asmaaelshahaby@gmail.com

Contact: Eman AboElhamd, Professor; +201001980793; dr.eman_08@yahoo.com

Sponsors and Collaborators

Asmaa Abdelmonem Ahmed

Assiut University

More Information

• Responsible Party: Asmaa Abdelmonem Ahmed, Assistant Lecturer, Assiut University
• ClinicalTrials.gov Identifier: NCT04863833
• Other Study ID Numbers: Tomosymthesis
• First Posted: April 28, 2021
• Last Update Posted: April 28, 2021
• Last Verified: April 2021

Keywords provided by Asmaa Abdelmonem Ahmed, Assiut University:

Tomosyntheses, X-ray--Digital Tomosynthesis-- Breast Tomosyntheses