New Mammographic Techniques Versus MRI in Assessment of Breast Lesions

NCT06089148 | Completed DMC

• 1 other identifier: 141014
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Value of New Mammography Techniques in Comparison to Dynamic Contrast-Enhanced MRI of the Breast in the Detection and Diagnosis of Breast lesions

Conditions

Breast Diseases

Outcome Measures

Primary Outcomes (1)

• sensitivity, specificity of'tomosynthesis and contrast enhanced mammography and MRI breast are measured in assessment of breast lesions and their pre-operative assessment of breast cancer

  diagnostic

  1year

Study Arms (1)

contrast enhanced mammography, tomosynthesis and MRI

CEDM and tomosynthesis versus MRI

Diagnostic Test: contrast enhanced digital mammography, tomosyntheis and MRI

Interventions

contrast enhanced digital mammography, tomosyntheis and MRI DIAGNOSTIC_TEST

contrast enhanced mammography, tomosynthesis and MRI

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

FEMALE

You may qualify if:

• Breast Imaging Reporting and Data System (BI-RADS) 3, 4, and 5 breast lesions.
• Clinical indication for MRI breast imaging.

You may not qualify if:

• \. Pregnancy or possible pregnancy. 2. History of allergy to an iodinated contrast agent. 3. Renal impairment. 4. Contraindication for MRI examination

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Breast Diseases

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR (lectureur)

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 18, 2023
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1year
• Access Criteria: http://www.medicine.cu.edu.eg/index.php/en/