Role of Contrast Enhanced Digital Mammography in Female Patients With Pathological Nipple Discharge
NCT ID: NCT04651257
Last Updated: 2020-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2020-12-31
2022-11-30
Brief Summary
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Detailed Description
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Majority of nipple discharge cases are more frequently due to benign conditions, so less operative ,nonsurgical methods can be applied to limit the need for surgical intervention , the woman that presents with nipple discharge should be managed as follow , ultrasound which is always performed in cases with nipple discharge for detection of ductal carcinoma in situ or invasive carcinoma , the sensitivity and specificity of ultrasound were 65% and 75% to 85%respectively ,mammography which plays an important role in diagnosis of breast diseases however it has low (20-25%)sensitivity in cases with nipple discharge as the associated lesions are usually retro areolar ,small, intraductal and non calcified so negative mammography do not exclude the possibility of underlying disease , ductography,which has long been considered the gold standard for evaluation of nipple discharge but it has low sensitivity , MRI has high sensitivity in evaluation of nipple discharge up to 88% to 95%, and its negative predictive value is (90%) , demonstrate not only ductal lesions but also lesions in adjacent parenchyma and it is superior in assessment of location and extent of a lesion.
Recently, contrast enhanced digital mammography has shown a very high sensitivity and specificity in diagnosis of breast lesions, it was approved by the U.S. Food and Drug Administration in 2011. The utility of CEM in the diagnostic setting for evaluation of breast lesion is 100% sensitivity, 87.7% specificity, 76.2%, positive predictive, 100%negative predictive .CEM has been found to result in more accurate tumor size estimation . In the evaluation of suspicious micro calcifications, the negative predictive value of CEM has been reported to be up to 93% . The literature also suggests that the improved performance of CEM relative to that of mammography is greater in women with dense breast tissue as compared with nondense breast tissue, with fewer false-negative cases . Additionally CEM can evaluate response to neoadjuvant chemotherapy and assessment of disease recurrence and also in screening of high risk women .
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Contrast mammography (CEM)
Contrast mammography in pathological nipple discharge
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
80 Years
FEMALE
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Marwa Mohamed Mosaad
principle investigator
Central Contacts
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References
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Morrogh M, Park A, Elkin EB, King TA. Lessons learned from 416 cases of nipple discharge of the breast. Am J Surg. 2010 Jul;200(1):73-80. doi: 10.1016/j.amjsurg.2009.06.021. Epub 2010 Jan 15.
Lippa N, Hurtevent-Labrot G, Ferron S, Boisserie-Lacroix M. Nipple discharge: The role of imaging. Diagn Interv Imaging. 2015 Oct;96(10):1017-32. doi: 10.1016/j.diii.2015.07.004.
Ashfaq A, Senior D, Pockaj BA, Wasif N, Pizzitola VJ, Giurescu ME, Gray RJ. Validation study of a modern treatment algorithm for nipple discharge. Am J Surg. 2014 Aug;208(2):222-7. doi: 10.1016/j.amjsurg.2013.12.035. Epub 2014 Apr 3.
Boisserie-Lacroix M, Adenet C, Trillaud H. [Evaluation of suspicious nipple discharge with MRI: review of 50 cases]. J Radiol. 2011 May;92(5):412-20. doi: 10.1016/j.jradio.2011.03.003. Epub 2011 May 7. French.
Other Identifiers
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CEM in nipple discharge
Identifier Type: -
Identifier Source: org_study_id