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)
40
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 |
---|---|---|
|
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
- 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
-
Breast Imaging Reporting and Data System (BI-RADS) 3, 4, and 5 breast lesions.
-
Clinical indication for MRI breast imaging.
-
No histologically proven cancer before enrollment. Exclusion criteria
-
Pregnancy or possible pregnancy. 2. History of allergy to an iodinated contrast agent.
-
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: