Value of Digital Breast Tomosynthesis in Breast Lesions

NCT06687902 | Active Not Recruiting

• 1 other identifier: Soh-Med-15-10---5MS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the added value of digital breast tomosynthesis (DBT) in the characterization of breast lesions.

Conditions

Digital Breast Tomosynthesis

Outcome Measures

Primary Outcomes (1)

• Compare DBT with traditional mammography in terms of diagnostic accuracy, sensitivity, and specificity for detecting and differentiating benign and malignant breast lesions

  1 hour

Study Arms (1)

Patients with breast lesions

EXPERIMENTAL

Diagnostic Test: Digital breast tomosynthesis

Interventions

Digital breast tomosynthesis DIAGNOSTIC_TEST

In digital breast tomosynthesis (DBT), images are acquired using a specialized X-ray tube that moves in an arc around the breast. This technique captures multiple low-dose images from various angles, typically within a 15° to 60° range. These images are then reconstructed into 1-mm slices to create a 3D representation of the breast, allowing for detailed layer-by-layer evaluation. The number of images acquired varies depending on the size of the breast and the specifications of the equipment but generally ranges from 10 to 25 projections, captured within a few seconds.

Patients with breast lesions

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with mammographic breast lesions of BIRADS III, IV.
• Dense breast in patients with complaints (BIRADS 0) which needed further assessment.

You may not qualify if:

• Pregnant females to avoid the hazards of ionizing radiation to the fetus.
• Patients with known metastatic breast cancer.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, 82749, Egypt

Location

MeSH Terms

Interventions

Mammography

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.B.B.Ch

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 14, 2024
• Study Start: October 9, 2024
• Primary Completion: September 10, 2025
• Study Completion: December 6, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)