CEDM&DBTVSMR: New Mammographic Techniques Versus MRI in Assessment of Breast Lesions

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06089148
• Collaborator: (none)
• Enrollment: 40
• Actual Duration (Months): 18

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Breast Diseases	Diagnostic Test: contrast enhanced digital mammography, tomosyntheis and MRI

Detailed Description

Combined use of contrast-enhanced digital mammography (CEDM), and digital breast tomosynthesis (DBT), may be a reasonable alternative to MRI.

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Value of New Mammography Techniques in Comparison to Dynamic Contrast-Enhanced MRI of the Breast in the Detection and Diagnosis of Breast Lesions
• Actual Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
contrast enhanced mammography, tomosynthesis and MRI CEDM and tomosynthesis versus MRI	Diagnostic Test: contrast enhanced digital mammography, tomosyntheis and MRI

Outcome Measures

Primary Outcome Measures

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 [1year]

   diagnostic

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion criteria

1. Breast Imaging Reporting and Data System (BI-RADS) 3, 4, and 5 breast lesions.

2. Clinical indication for MRI breast imaging.

3. No histologically proven cancer before enrollment. Exclusion criteria

4. Pregnancy or possible pregnancy. 2. History of allergy to an iodinated contrast agent.

5. Renal impairment. 4. Contraindication for MRI examination

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marwa A Haggag, DR (lectureur), Cairo University
• ClinicalTrials.gov Identifier: NCT06089148
• Other Study ID Numbers: 141014
• First Posted: Oct 18, 2023
• Last Update Posted: Oct 18, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Diseases

Study Results

No Results Posted as of Oct 18, 2023