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Status unknownNCT04651257Updated Dec 3, 2020

Role of Contrast Enhanced Digital Mammography in Female Patients With Pathological Nipple Discharge

An observational study in Contrast Mammography in Pathological Nipple Discharge, sponsored by Assiut University. Status unknown. Open to female participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-12-03.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
20 Years to 80 Years
Sex
Female
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Study summary

To evaluate the validity of contrast enhanced digital mammography in evaluation of pathological nipple discharge .

Read the detailed description

Nipple discharge is a relatively frequent complaint in females, being the third most common breast symptoms prompting medical care, after breast pain and breast palpable mass. Over 80% of females will have an episode of nipple discharge during their fertile life,which can be categorized as lactional which is milky in nature and occur during pregnancy or breast feeding. Physiological nipple discharge, is yellow, milky or greenish in nature, it cannot happen spontaneously and it can often be seen coming from multiple orifices,Some causes of physiological nipple discharge are hypothyroidism and medication side-effects. . Pathological nipple discharge is defined as a clear, serous, or bloody secretion , spontaneous, discharging from a single duct and unilateral. It is frequently caused by a benign lesion, such as intraductal papilloma (35-56%) or ductal ectasia (6-59%), but an underlying malignancy can be present in a percentage of cases reported to be variable from 5 to 33%.

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 .

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Conditions studied

  • Contrast Mammography in Pathological Nipple Discharge
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

This study will include 40 patients with pathological nipple discharge

Inclusion criteria

1_in diagnosis of female patients with pathological nipple discharge

Exclusion criteria

Exclusion Criteria:

    1. Patients with renal failure or with raised renal chemistry 2-patients who are allergic to contrast 2. Pregnant women
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Interventions

  • DeviceContrast mammography (CEM)

    Contrast mammography in pathological nipple discharge

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What researchers measure

Primary outcomes

  1. To correlate results of CEM with histopathology (TCNB,FNAC,surgical excision) in female patients with pathological nipple discharge .

    Pathological nipple discharge has several causes ,inflammatory ,malignant ,benign lesion , this will be evaluated by CEM and correlate the results with histopatholgy of the cases .

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 20079481 ↗
  • 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. PubMed 26433322 ↗
  • 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. PubMed 24767970 ↗
  • 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. PubMed 21621107 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04651257
Lead sponsor
Assiut University
Responsible party
Marwa Mohamed Mosaad (principle investigator, Assiut University) — Principal investigator
First posted
Dec 3, 2020
Start date
Dec 2020 (estimated)
Primary completion
Sep 2022 (estimated)
Completion
Nov 2022 (estimated)
Last update
Dec 3, 2020

Study contacts

Marwa Mohamed Mosaad
Contact
Marweka6@gmail.com
01002737790
Moustafa Ahmed Mamdouh, prof.Dr
Contact
Drmostafamri@yahoo.com
01223971443

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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