The Added Value of DBT Over Mammography in Local Tumor Staging in Patients With BIRADS 4 or 5 Lesions

NCT06854887 | Not Yet Recruiting

• 1 other identifier: DBT &Mammography in BIRADS 4-5
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

Compare the diagnostic accuracy of tomosynthesis with 2D mammography in cases with suspected BI-RADS 4 or 5 to determine its potential benefit for staging

Conditions

Digital Breast Tomosynthesis

Outcome Measures

Primary Outcomes (5)

• Recording The breast density in both tomosynthesis and mammography for the main and satellite lesions

  The breast density according to ACR BIRADS in both tomosynthesis and mammography for the main and satellite lesions

  baseline

• Recording the type of lesion in both tomosynthesis and mammography for the main and satellite lesions

  the type of lesion (mass , microcalcification , architectural distortion) in both tomosynthesis and mammography for the main and satellite lesions

  baseline

• Recording the probability of multifocality or multicentricity in both tomosynthesis and mammography for the main and satellite lesions

  the probability of multifocality or multicentricity in both tomosynthesis and mammography for the main and satellite lesions

  baseline

• Recording the location of the tumor within the mammary quadrants and the depth of the tumor in both tomosynthesis and mammography for the main and satellite lesions

  The location of the tumor within the mammary quadrants (upper , lower , outer , inner ) and the depth (anterior-middle-posterior) of the tumor in both tomosynthesis and mammography for the main and satellite lesions

  baseline

• Recording the tumor histopathology type for the main and satellite lesions

  Recording the tumor histopathology type (ductal, lobular , in situ , others) for the main and satellite lesions

  baseline

Interventions

digital breast tomosynthesis and mammography DEVICE

tomosynthesis is 3D image for the breast mammography is 2D image for the breast

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study included patients with BIRADS 4 or 5 lesions who pathologically proved to be breast cancer by TCNB

You may qualify if:

• BI-RADS 4 OR 5 LESION that pathologically proved to be breast cancer.
• No history of previous operations
• No history of chemotherapy or radiotherapy

You may not qualify if:

• BI-RADS 1 ,2,3 lesions
• History of previous operation

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Mariscotti G, Durando M, Houssami N, Fasciano M, Tagliafico A, Bosco D, Casella C, Bogetti C, Bergamasco L, Fonio P, Gandini G. Comparison of synthetic mammography, reconstructed from digital breast tomosynthesis, and digital mammography: evaluation of lesion conspicuity and BI-RADS assessment categories. Breast Cancer Res Treat. 2017 Dec;166(3):765-773. doi: 10.1007/s10549-017-4458-3. Epub 2017 Aug 17.

  PMID: 28819781 RESULT

• Bernardi D, Belli P, Benelli E, Brancato B, Bucchi L, Calabrese M, Carbonaro LA, Caumo F, Cavallo-Marincola B, Clauser P, Fedato C, Frigerio A, Galli V, Giordano L, Giorgi Rossi P, Golinelli P, Morrone D, Mariscotti G, Martincich L, Montemezzi S, Naldoni C, Paduos A, Panizza P, Pediconi F, Querci F, Rizzo A, Saguatti G, Tagliafico A, Trimboli RM, Zappa M, Zuiani C, Sardanelli F. Digital breast tomosynthesis (DBT): recommendations from the Italian College of Breast Radiologists (ICBR) by the Italian Society of Medical Radiology (SIRM) and the Italian Group for Mammography Screening (GISMa). Radiol Med. 2017 Oct;122(10):723-730. doi: 10.1007/s11547-017-0769-z. Epub 2017 May 25.

  PMID: 28540564 RESULT

• Marinovich ML, Hunter KE, Macaskill P, Houssami N. Breast Cancer Screening Using Tomosynthesis or Mammography: A Meta-analysis of Cancer Detection and Recall. J Natl Cancer Inst. 2018 Sep 1;110(9):942-949. doi: 10.1093/jnci/djy121.

  PMID: 30107542 RESULT

MeSH Terms

Interventions

Mammography

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Silvia Gamal Rasmy

CONTACT

+201289374337; dsilviajesus@gmail.com

Eman Abo Elhamd

CONTACT

+201001980793; dr.eman_08@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: February 28, 2025
• Primary Completion: March 29, 2026
• Study Completion: April 1, 2026
• Last Updated: March 3, 2025

Record last verified: 2025-02