Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Galactorrhea

Breast Diseases

Skin Diseases

Lactation Disorders

Puerperal Disorders

Pregnancy Complications

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

all participants will receive Magnetic Resonance Ductography (MRD) and High-Resolution Magnetic Resonance Ductography (HR-MRD) examination, using breast dedicated coil and microscopic coil, respectively

Magnetic Resonance Ductography (MRD); and High-Resolution Magnetic Resonance Ductography (HR-MRD)

Yue Hu, MD.

Nipple discharge is one of the common symptoms of breast disease patients. Nipple discharge can be divided into physiological and pathological nipple discharge (PND). Among patients with PND symptoms who undergo biopsy, 5%-21% of them are malignant, and the risk of malignancy increases with age. The primary diagnostic imaging methods for PND patients include mammography and breast ultrasound. Nearly half of PND patients who undergo traditional mammography and ultrasound examination have negative findings, but this does not rule out the presence of malignant lesions. Central duct excision is the gold standard for PND diagnosis, but invasive surgery without imaging guidance can lead to some complications. Magnetic Resonance Ductography (MRD), which uses water imaging technology to visualize the inside of the duct without contrast injection, can show imaging features of ductal lesions such as filling defects, irregularities of duct walls, and ductal obstruction. However, previous studies have shown that the signal-to-noise ratio of MRD images needs to be improved. Microscopy coil has the characteristics of small voxels and high spatial resolution, making it suitable for high signal-to-noise ratio imaging of small superficial structures. This provides a hardware foundation for improving the quality of MRD images. Therefore, in this study, the investigators aim to use the 3T MR instrument and microscopy coil to perform non-invasive high-resolution Magnetic Resonance Ductography (HR-MRD) on PND patients to evaluate the ability of HR-MRD to detect PND causes and the imaging features of duct-related lesions on HR-MRD, to assist in the accurate diagnosis and treatment of PND.

Clinical Value of Breast High-Resolution MR Ductography in Patients With Pathological Nipple Discharge

Clinical Value of Breast High-Resolution MR Ductography in Patients With Pathological Nipple Discharge: A Prospective, Exploratory Diagnostic Study

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Papilloma

Papilloma, Intraductal

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ductoscopic papillectomy to treat pathological nipple discharge

Intraductal papilloma extraction through the nipple orifice by interventional ductoscopy

Ductoscopic papillectomy

Sheldon Feldman, MD

In this prospective clinical trial, patients who sign an approved informed consent for ductoscopy to assess etiology of Pathologic nipple discharge (PND) will be enrolled in the study. Consented patients who have been diagnosed with a solitary papilloma within the discharging duct will be recruited to have interventional ductoscopy.

Patients who are identified ductoscopically with a solitary non-sessile papilloma will undergo an attempted ductoscopic papillectomy (DP). Patients with ductoscopic findings other than single non-sessile papilloma will undergo standard ductoscopically guided microductectomy. The investigators will investigate whether the ductoscopic basket can be used as a safe endoscopic extraction instrument without adverse events. Histopathological evaluation will be performed to confirm the ductoscopic diagnosis and to determine the existence of any malignant tissue.

Nipple discharge is the third most common breast related symptom for which women seek medical care, accounting for 37% of all breast complaints. Pathologic nipple discharge (PND) is defined as spontaneous or easily expressible single duct nipple discharge, which contributes to 5% of referrals to breast surgeons. Patients with PND represent a diagnostic and therapeutic challenge for the surgical clinician. The most frequent causes of PND in these cases are intraductal papilloma (IP) in 36% to 66%, ductal carcinoma in situ (DCIS) in 3% to 20% and other benign causes in up to 23%. The evaluation of women with PND usually involves radiological(mammography, ultrasound, ducto (galacto)graphy and cytological (nipple smear, ductal lavage) examinations; however, each of these procedures has found to have low sensitivity and specificity. A ductoscope is an instrument which allows visualization of abnormalities and polypoid lesions within the ductal system with access via the nipple orifice to aid in evaluation of PND. Moreover, it is currently being used to improve localization of lesions in patients with PND. Ductoscopically guided excision is an improvement over standard surgical approaches with terminal duct excision which removes a large volume of tissue with potential cosmetic deformity and for young women may make breast feeding not possible. Ductoscopy also allows retrieval of intraductal cells for diagnostic purposes using brush cytology.

Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge

Technical success will be determined by complete (total ductoscopic retrieval of a papilloma) ductoscopic retrieval of lesions over 90% of enrolled patients diagnosed with solitary papilloma.

Therapeutic success will be determined by cessation after ductoscopic papillectomy (DP) in over 95% of enrolled patients with pathologic nipple discharge (PND) with a single papilloma.

Patients will be monitored for recurrence of nipple discharge at 6 month intervals for 2 years.

Columbia University

Montefiore Medical Center

Five participants were excluded for not meeting protocol inclusion/exclusion criteria (i.e., screen failed) immediately following enrollment and did not participate in the study procedure.

Four participants proceeded with the procedure. All four participants did not complete the study as the surgeon was unable to cannulate the ductal system or the patient was found to not have a solitary papilloma.

Ductoscopic papillectomy to treat pathological nipple discharge

Ductoscopic papillectomy: Intraductal papilloma extraction through the nipple orifice by interventional ductoscopy

Ductoscopic Papillectomy

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Sheldon Feldman, Chief Breast Surgery and Breast Surgery Oncology

Data related to the number of complete ductoscopic retrievals was not collected and analyzed.

Number of Complete Ductoscopic Retrievals

Data related to the number of participants with cessation of nipple discharge after ductoscopic papillectomy was not collected and analyzed.

Number of Patients With Cessation of Nipple Discharge

Data related to the recurrence of nipple discharge was not collected and analyzed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Value of Breast High-Resolution MR Ductography in Patients With Pathological Nipple Discharge	NCT05812040	Breast Neoplasm... Nipple Discharg...	Magnetic Resona...	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Clinical Value of Breast High-Resolution MR Ductography in Patients With Pathological Nipple Discharge	NCT05812040	Breast Neoplasm... Nipple Discharg...	Magnetic Resona...	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge	NCT01901562	Breast Discharg... Intraductal Pap...	Ductoscopic pap...	18 Years -	Montefiore Medical Center
Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge	NCT01901562	Breast Discharg... Intraductal Pap...	Ductoscopic pap...	18 Years -	Montefiore Medical Center

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