Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04651257
Status:
UNKNOWN
Last Update Posted:
2020-12-03
First Post:
2020-09-26
Brief Title:
Role of Contrast Enhanced Digital Mammography in Female Patients With Pathological Nipple Discharge
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Role of Contrast Enhanced Digital Mammography in Female Patients With Pathological Nipple Discharge
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the validity of contrast enhanced digital mammography in evaluation of pathological nipple discharge
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 lifewhich 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 orificesSome 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 85respectively mammography which plays an important role in diagnosis of breast diseases however it has low 20-25sensitivity 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 ductographywhich 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 US Food and Drug Administration in 2011 The utility of CEM in the diagnostic setting for evaluation of breast lesion is 100 sensitivity 877 specificity 762 positive predictive 100negative 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
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 85respectively mammography which plays an important role in diagnosis of breast diseases however it has low 20-25sensitivity 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 ductographywhich 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 US Food and Drug Administration in 2011 The utility of CEM in the diagnostic setting for evaluation of breast lesion is 100 sensitivity 877 specificity 762 positive predictive 100negative 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None