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

November 26, 2020 updated by: Marwa Mohamed Mosaad, Assiut University
To evaluate the validity of contrast enhanced digital mammography in evaluation of pathological nipple discharge .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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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 .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

This study will include 40 patients with pathological nipple discharge

Description

Inclusion Criteria:

1_in diagnosis of female patients with pathological nipple discharge

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To correlate results of CEM with histopathology (TCNB,FNAC,surgical excision) in female patients with pathological nipple discharge .
Time Frame: Baseline
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 .
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CEM in nipple discharge

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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