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Contrast Mammography in Pathological Nipple DischargeNCT04651257

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

An observational study of Contrast Mammography in Pathological Nipple Discharge, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the validity of contrast enhanced digital mammography in evaluation of pathological nipple discharge . Read more about this study

Who is it for?
Ages 20 to 80 years, women only
What is being tested?
Contrast mammography (CEM)
Type of treatment
Medical device
How many people
40 participants
Where
No sites listed yet
Study dates
Dec 2020to Nov 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • Women only
  • Adult, Older adult

Study population: This study will include 40 patients with pathological nipple discharge

Who may be able to join

  • 1in diagnosis of female patients with pathological nipple discharge

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Marwa Mohamed Mosaad contact

01002737790

Marweka6@gmail.com

Moustafa Ahmed Mamdouh, prof.Dr contact

01223971443

Drmostafamri@yahoo.com

About this study

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 .

Being tested
Contrast mammography (CEM)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contrast mammography (CEM)Device

    Contrast mammography in pathological nipple discharge

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 .

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2020
  2. Study startDec 2020 (estimated)
  3. Primary completionSep 2022 (estimated)
  4. Study completionNov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04651257
Sponsor's protocol ID
CEM in nipple discharge
Status last verified
Nov 2020
First submitted
26 Sep 2020
Last updated
3 Dec 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Contrast Mammography in Pathological Nipple Discharge, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marwa Mohamed Mosaad (01002737790, Marweka6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To correlate results of CEM with histopathology (TCNB,FNAC,surgical excision) in female patients with pathological nipple discharge . (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04651257, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.

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