Diagnostic Utility of MRI in Female Patients With Nipple Discharge: A Prospective Trial
NCT ID: NCT02818946
Last Updated: 2020-01-07
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-07-31
Study Completion Date
2019-08-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of the proposed prospective study is to determine the diagnostic value of MRI for the evaluation of patients with pathologic nipple discharge. Breast surgeons will identify clinic patients with pathologic nipple discharge (unilateral and bloody or unilateral and clear) and refer them for breast MRI. When the clinical team notifies the study team that an MRI has been ordered for that purpose, the study team will consent patients to document the results and follow-up. The study team will not be obtaining MRI's on patients for research purposes only. The following data will be collected and analyzed: patient age, characteristics of the discharge (laterality, spontaneous versus expressed, duration of time, color, presence of blood), imaging workup and findings, BI-RADS final assessment categories, pathology results from core biopsy and/or surgical excision, and clinical and radiologic follow-up data during the two years after presentation. Participation in this study poses minimal risk to patients. Risks to the subjects include loss of confidentiality and unnecessary breast biopsy. The risks associated with MRI are minimal; however, since a gadolinium-based contrast agent will be administered for the MRI, patients with compromised renal function and patients who are pregnant will be excluded from the study.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Benefit of a Diagnostic MRI in Case of Pathological Nipple Discharge With Normal Mammography / Ultrasound
NCT02819362
Breast Cancer
COMPLETED
Clinical Value of Breast High-Resolution MR Ductography in Patients With Pathological Nipple Discharge
NCT05812040
Breast Neoplasms
Nipple Discharge
RECRUITING
NA
MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ
NCT00874458
Breast Cancer
COMPLETED
NA
Evaluate The Accuracy Of Breast MRI Biopsy In Diagnosing A Complete Tumor Response For Some Women Following Neoadjuvant Chemotherapy For Breast Cancer
NCT03289195
Breast Cancer
ACTIVE_NOT_RECRUITING
NA
Breast MRI as a Preoperative Tool for DCIS
NCT00605982
Breast Cancer
Ductal Carcinoma in Situ
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Purpose of the Study:
The purpose of this prospective study is to determine the diagnostic value of Magnetic Resonance Imaging (MRI) for the evaluation of patients with pathologic nipple discharge.
Background \& Significance:
Nipple discharge, one of the most common reasons for referral to the breast imaging service, is often investigated by diagnostic mammography and sonography to evaluate for an underlying malignancy, the reported incidence of which ranges from 3 to 29%. If conventional imaging is negative, the patient may obtain further imaging with MRI, undergo ductography or ductoscopy, proceed to duct exploration and excision, or be observed. Findings on breast MRI, in addition to the patient's symptomatology (frequency and volume of discharge) and risk of breast cancer, are used to inform the decision about whether to pursue surgery or watchful waiting.
Limited research suggests that MRI may have a role in the evaluation of patients with nipple discharge because of its ability to identify mammographically- and sonographically-occult disease and to guide surgical excision. Previous research has drawn conclusions from small retrospective patient cohorts, and there is relatively wide variability in the reported diagnostic utility of MRI. Consequently, duct exploration and excision remains the gold standard diagnostic approach. However, duct excision is an invasive procedure that can be technically challenging, especially if the affected duct cannot be localized or if the intraductal lesion is located far posteriorly in the breast, and can result in complications, such as interruption of the neurovascular supply to the nipple-areolar complex, cosmetic deformity, and breastfeeding limitations.
Many women with nipple discharge and a negative conventional imaging workup undergo surgical excision, but few actually have underlying malignancy. MRI may be useful to improve patient selection in this setting; in particular, a high negative predictive value of MRI may obviate the need for invasive surgery in patients who do not require intervention for symptomatic relief. Our research group previously performed a retrospective study on this topic, which is currently under review for publication. The negative predictive value of MRI was found to be 100%, but this study was significantly limited by selection bias; that is, only certain patients, at the discretion of the breast surgeon, underwent MRI as part of their workup.
The purpose of the proposed prospective study is to determine the diagnostic value of MRI for the evaluation of patients with pathologic nipple discharge.
Design \& Procedures:
Referral for breast MRI in patients with pathological nipple discharge has changed in recent years. Discussion with breast surgeons indicate that referral for breast MRI has become routine for patients who present with pathological nipple discharge when in the past, referral was at the discretion of the breast surgeon. For this study, patients with pathologic nipple discharge (unilateral and bloody or unilateral and clear) will be identified in either surgery clinic with presenting symptoms or in breast imaging clinic in one of 2 ways: 1) on the requisition under the "indication for exam" as specified by the referring clinician, or 2) by the technologist who asks routine questions to the patient. These patients will undergo conventional imaging with mammography and breast sonography first. If conventional imaging is negative or non-diagnostic, the patient will be seen in surgical clinic (Clinic 2-2 next door) and contrast-enhanced breast MRI will be ordered by the surgeon as part of clinical care. All patients will see a breast surgeon first before being approached for the study. Once a patient is identified as having a planned contrast MRI, they will be approached by a Clinical Research Coordinator (CRC) or resident/fellow participating in the study. Our experience, based on a prior retrospective nipple discharge study, has shown that approximately 100 patients per year are encountered at the breast imaging clinic for evaluation of nipple discharge. It is expected that approximately 75% will agree to participate in the study. This will yield a recruitment rate of 75 patients per year, hence the number specified in the study proposal. Bracco Diagnostics will provide seed funding for 2 years for an anticipated total of 150 patients.
Data will only be acquired prospectively on patients who receive MRI's for clinical purposes (symptoms of pathological nipple discharge). When the clinical team notifies the study team that an MRI has been ordered for that purpose, the study team will consent the patients to document the results and follow-up. MRI's will not be obtained on patient's for research purposes only. For that reason, clinical guidelines for obtaining creatinine, pregnancy tests, etc will be followed.
The following data will be collected and analyzed: patient age, characteristics of the discharge (laterality, spontaneous versus expressed, duration of time, color, presence of blood), imaging workup and findings, Breast Imaging-Reporting and Data Systems (BI-RADS) final assessment categories, pathology results from core biopsy and/or surgical excision, and clinical and radiologic follow-up data during the two years after presentation.
Selection of Subjects:
See above detailed paragraph.
Inclusion criteria: female patients with unilateral and bloody nipple discharge OR unilateral and clear nipple discharge; clinical decision to have contrast enhanced MRI.
Exclusion criteria: male gender, non-English speakers, age \< 21 years, lack of capacity to give legally effective consent
Note: It is highly unusual for lactating patients to present with pathologic discharge and therefore will likely not be identified for the study. There is a very small potential risk associated with absorption of contrast medium into the breast milk, but there is insufficient evidence to exclude women who are currently lactating from the study.
Note: The costs of MRI will be covered by insurance. In the unlikely event that a patient's insurance denies coverage, the patient will be excluded from the study.
Subject Recruitment \& Compensation:
The patient will be seen in surgical clinic (Clinic 2-2 next door) and contrast-enhanced breast MRI will be ordered by the surgeon. Potential subjects will be contacted and introduced to the study by the designated Clinical Research Coordinator or resident/fellow participating in the project.
Recruitment will begin after approval of the Institutional Review Board (IRB) and conclude after recruitment of approximately 150 subjects. No financial compensation to subjects will be provided.
Consent Process:
Please see Section 14 of the e-IRB submission form.
Subject's Capacity to Give Legally Effective Consent:
Subjects who do not have the capacity to give legally effective consent will not be included in this study.
Study Interventions:
Patients who choose to participate in this trial will have undergone mammography, breast sonography, and will be planning to have a contrast-enhanced breast MRI for evaluation of nipple discharge. The study interventions are collection of clinical data for research purposes.
Risk/Benefit Assessment:
Participation in this study poses minimal risk to patients. Risks to the subjects include loss of confidentiality.
Loss of confidentiality is unlikely because the study data will be stored in the Principal Investigator's (PI's) office and a shared drive.
There will not be any direct benefit to the subjects; however, this research may help improve the diagnostic workup of nipple discharge in future patients.
Costs to the Subject:
There is no cost to the subject as a result of this study. The costs of the MRI will be covered by insurance. No financial compensation will be provided.
Data Analysis \& Statistical Considerations:
As discussed above, a high negative predictive value of MRI may obviate the need for invasive surgery in patients who do not require intervention for symptomatic relief. Based on a statistical consultation with Dr. Kingshuk Roy Choudhary, a negative predictive value of MRI of 95% with a margin of error of +/- 4.3% can be achieved if 100 subjects are recruited. The goal is to recruit approximately 150 subjects, with the expectation that some patients will not receive adequate two-year follow-up.
The following data will be collected and analyzed: patient age, characteristics of the discharge (laterality, spontaneous versus expressed, duration of time, color, presence of blood), imaging workup and findings, BI-RADS final assessment categories, pathology results from core biopsy and/or surgical excision, and clinical and radiologic follow-up data during the two years after presentation.
The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for MRI for the detection of malignancy will be calculated using standard formulas. MRIs classified as BI-RADS categories 4 and 5 will be considered "positive," while those classified as BI-RADS categories 1, 2, and 3 will be considered "negative." For purposes of the analysis, MRI will be considered to be "false positive" imaging if the biopsied and/or excised lesion does not reveal malignancy. MRI will be considered "false negative" imaging if there is no suspicious finding on imaging (BI-RADS 1, 2, or 3) but subsequent pathology reveals malignancy.
13\. Data \& Safety Monitoring: Consent forms will be stored in the PI's office. Patient names and medical record numbers will be recorded in a database on a shared drive only accessible by study researchers. Once data collection is completed, these identifiers will be discarded. Only basic demographic information (age) will be retained.
The purpose of this prospective study is to determine the diagnostic value of Magnetic Resonance Imaging (MRI) for the evaluation of patients with pathologic nipple discharge.
Background \& Significance:
Nipple discharge, one of the most common reasons for referral to the breast imaging service, is often investigated by diagnostic mammography and sonography to evaluate for an underlying malignancy, the reported incidence of which ranges from 3 to 29%. If conventional imaging is negative, the patient may obtain further imaging with MRI, undergo ductography or ductoscopy, proceed to duct exploration and excision, or be observed. Findings on breast MRI, in addition to the patient's symptomatology (frequency and volume of discharge) and risk of breast cancer, are used to inform the decision about whether to pursue surgery or watchful waiting.
Limited research suggests that MRI may have a role in the evaluation of patients with nipple discharge because of its ability to identify mammographically- and sonographically-occult disease and to guide surgical excision. Previous research has drawn conclusions from small retrospective patient cohorts, and there is relatively wide variability in the reported diagnostic utility of MRI. Consequently, duct exploration and excision remains the gold standard diagnostic approach. However, duct excision is an invasive procedure that can be technically challenging, especially if the affected duct cannot be localized or if the intraductal lesion is located far posteriorly in the breast, and can result in complications, such as interruption of the neurovascular supply to the nipple-areolar complex, cosmetic deformity, and breastfeeding limitations.
Many women with nipple discharge and a negative conventional imaging workup undergo surgical excision, but few actually have underlying malignancy. MRI may be useful to improve patient selection in this setting; in particular, a high negative predictive value of MRI may obviate the need for invasive surgery in patients who do not require intervention for symptomatic relief. Our research group previously performed a retrospective study on this topic, which is currently under review for publication. The negative predictive value of MRI was found to be 100%, but this study was significantly limited by selection bias; that is, only certain patients, at the discretion of the breast surgeon, underwent MRI as part of their workup.
The purpose of the proposed prospective study is to determine the diagnostic value of MRI for the evaluation of patients with pathologic nipple discharge.
Design \& Procedures:
Referral for breast MRI in patients with pathological nipple discharge has changed in recent years. Discussion with breast surgeons indicate that referral for breast MRI has become routine for patients who present with pathological nipple discharge when in the past, referral was at the discretion of the breast surgeon. For this study, patients with pathologic nipple discharge (unilateral and bloody or unilateral and clear) will be identified in either surgery clinic with presenting symptoms or in breast imaging clinic in one of 2 ways: 1) on the requisition under the "indication for exam" as specified by the referring clinician, or 2) by the technologist who asks routine questions to the patient. These patients will undergo conventional imaging with mammography and breast sonography first. If conventional imaging is negative or non-diagnostic, the patient will be seen in surgical clinic (Clinic 2-2 next door) and contrast-enhanced breast MRI will be ordered by the surgeon as part of clinical care. All patients will see a breast surgeon first before being approached for the study. Once a patient is identified as having a planned contrast MRI, they will be approached by a Clinical Research Coordinator (CRC) or resident/fellow participating in the study. Our experience, based on a prior retrospective nipple discharge study, has shown that approximately 100 patients per year are encountered at the breast imaging clinic for evaluation of nipple discharge. It is expected that approximately 75% will agree to participate in the study. This will yield a recruitment rate of 75 patients per year, hence the number specified in the study proposal. Bracco Diagnostics will provide seed funding for 2 years for an anticipated total of 150 patients.
Data will only be acquired prospectively on patients who receive MRI's for clinical purposes (symptoms of pathological nipple discharge). When the clinical team notifies the study team that an MRI has been ordered for that purpose, the study team will consent the patients to document the results and follow-up. MRI's will not be obtained on patient's for research purposes only. For that reason, clinical guidelines for obtaining creatinine, pregnancy tests, etc will be followed.
The following data will be collected and analyzed: patient age, characteristics of the discharge (laterality, spontaneous versus expressed, duration of time, color, presence of blood), imaging workup and findings, Breast Imaging-Reporting and Data Systems (BI-RADS) final assessment categories, pathology results from core biopsy and/or surgical excision, and clinical and radiologic follow-up data during the two years after presentation.
Selection of Subjects:
See above detailed paragraph.
Inclusion criteria: female patients with unilateral and bloody nipple discharge OR unilateral and clear nipple discharge; clinical decision to have contrast enhanced MRI.
Exclusion criteria: male gender, non-English speakers, age \< 21 years, lack of capacity to give legally effective consent
Note: It is highly unusual for lactating patients to present with pathologic discharge and therefore will likely not be identified for the study. There is a very small potential risk associated with absorption of contrast medium into the breast milk, but there is insufficient evidence to exclude women who are currently lactating from the study.
Note: The costs of MRI will be covered by insurance. In the unlikely event that a patient's insurance denies coverage, the patient will be excluded from the study.
Subject Recruitment \& Compensation:
The patient will be seen in surgical clinic (Clinic 2-2 next door) and contrast-enhanced breast MRI will be ordered by the surgeon. Potential subjects will be contacted and introduced to the study by the designated Clinical Research Coordinator or resident/fellow participating in the project.
Recruitment will begin after approval of the Institutional Review Board (IRB) and conclude after recruitment of approximately 150 subjects. No financial compensation to subjects will be provided.
Consent Process:
Please see Section 14 of the e-IRB submission form.
Subject's Capacity to Give Legally Effective Consent:
Subjects who do not have the capacity to give legally effective consent will not be included in this study.
Study Interventions:
Patients who choose to participate in this trial will have undergone mammography, breast sonography, and will be planning to have a contrast-enhanced breast MRI for evaluation of nipple discharge. The study interventions are collection of clinical data for research purposes.
Risk/Benefit Assessment:
Participation in this study poses minimal risk to patients. Risks to the subjects include loss of confidentiality.
Loss of confidentiality is unlikely because the study data will be stored in the Principal Investigator's (PI's) office and a shared drive.
There will not be any direct benefit to the subjects; however, this research may help improve the diagnostic workup of nipple discharge in future patients.
Costs to the Subject:
There is no cost to the subject as a result of this study. The costs of the MRI will be covered by insurance. No financial compensation will be provided.
Data Analysis \& Statistical Considerations:
As discussed above, a high negative predictive value of MRI may obviate the need for invasive surgery in patients who do not require intervention for symptomatic relief. Based on a statistical consultation with Dr. Kingshuk Roy Choudhary, a negative predictive value of MRI of 95% with a margin of error of +/- 4.3% can be achieved if 100 subjects are recruited. The goal is to recruit approximately 150 subjects, with the expectation that some patients will not receive adequate two-year follow-up.
The following data will be collected and analyzed: patient age, characteristics of the discharge (laterality, spontaneous versus expressed, duration of time, color, presence of blood), imaging workup and findings, BI-RADS final assessment categories, pathology results from core biopsy and/or surgical excision, and clinical and radiologic follow-up data during the two years after presentation.
The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for MRI for the detection of malignancy will be calculated using standard formulas. MRIs classified as BI-RADS categories 4 and 5 will be considered "positive," while those classified as BI-RADS categories 1, 2, and 3 will be considered "negative." For purposes of the analysis, MRI will be considered to be "false positive" imaging if the biopsied and/or excised lesion does not reveal malignancy. MRI will be considered "false negative" imaging if there is no suspicious finding on imaging (BI-RADS 1, 2, or 3) but subsequent pathology reveals malignancy.
13\. Data \& Safety Monitoring: Consent forms will be stored in the PI's office. Patient names and medical record numbers will be recorded in a database on a shared drive only accessible by study researchers. Once data collection is completed, these identifiers will be discarded. Only basic demographic information (age) will be retained.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Disorder of Nipple
Breast Neoplasms
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MRI
Patients who have undergone mammography, breast sonography, and planning to have a contrast-enhanced breast MRI for evaluation of nipple discharge.
Group Type
OTHER
MRI
Intervention Type
DEVICE
Detection of cancer by MRI for pathologic nipple discharge
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MRI
Detection of cancer by MRI for pathologic nipple discharge
Intervention Type
DEVICE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* female patients with unilateral and bloody nipple discharge OR unilateral and clear nipple discharge
* clinical decision to have contrast enhanced MRI
* clinical decision to have contrast enhanced MRI
Exclusion Criteria
* male gender
* non-English speakers
* age \< 21 years
* lack of capacity to give legally effective consent
* non-English speakers
* age \< 21 years
* lack of capacity to give legally effective consent
Minimum Eligible Age
22 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bracco Diagnostics, Inc
INDUSTRY
Sponsor Role
collaborator
Duke University
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sujata Ghate, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Duke University Medical Center
Durham, North Carolina, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Kooistra BW, Wauters C, van de Ven S, Strobbe L. The diagnostic value of nipple discharge cytology in 618 consecutive patients. Eur J Surg Oncol. 2009 Jun;35(6):573-7. doi: 10.1016/j.ejso.2008.09.009. Epub 2008 Nov 4.
Reference Type
BACKGROUND
Lorenzon M, Zuiani C, Linda A, Londero V, Girometti R, Bazzocchi M. Magnetic resonance imaging in patients with nipple discharge: should we recommend it? Eur Radiol. 2011 May;21(5):899-907. doi: 10.1007/s00330-010-2009-y. Epub 2010 Nov 30.
Reference Type
BACKGROUND
Fisher CS, Margenthaler JA. A look into the ductoscope: its role in pathologic nipple discharge. Ann Surg Oncol. 2011 Oct;18(11):3187-91. doi: 10.1245/s10434-011-1962-2. Epub 2011 Aug 23.
Reference Type
BACKGROUND
Hussain AN, Policarpio C, Vincent MT. Evaluating nipple discharge. Obstet Gynecol Surv. 2006 Apr;61(4):278-83. doi: 10.1097/01.ogx.0000210242.44171.f6.
Reference Type
BACKGROUND
Rissanen T, Reinikainen H, Apaja-Sarkkinen M. Breast sonography in localizing the cause of nipple discharge: comparison with galactography in 52 patients. J Ultrasound Med. 2007 Aug;26(8):1031-9. doi: 10.7863/jum.2007.26.8.1031.
Reference Type
BACKGROUND
Sabel MS, Helvie MA, Breslin T, Curry A, Diehl KM, Cimmino VM, Chang AE, Newman LA. Is duct excision still necessary for all cases of suspicious nipple discharge? Breast J. 2012 Mar-Apr;18(2):157-62. doi: 10.1111/j.1524-4741.2011.01207.x. Epub 2011 Dec 30.
Reference Type
BACKGROUND
Bahl M, Baker JA, Greenup RA, Ghate SV. Diagnostic Value of Ultrasound in Female Patients With Nipple Discharge. AJR Am J Roentgenol. 2015 Jul;205(1):203-8. doi: 10.2214/AJR.14.13354.
Reference Type
BACKGROUND
Gray RJ, Pockaj BA, Karstaedt PJ. Navigating murky waters: a modern treatment algorithm for nipple discharge. Am J Surg. 2007 Dec;194(6):850-4; discussion 854-5. doi: 10.1016/j.amjsurg.2007.08.027.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Orel SG, Dougherty CS, Reynolds C, Czerniecki BJ, Siegelman ES, Schnall MD. MR imaging in patients with nipple discharge: initial experience. Radiology. 2000 Jul;216(1):248-54. doi: 10.1148/radiology.216.1.r00jn28248.
Reference Type
BACKGROUND
Morrogh M, Morris EA, Liberman L, Borgen PI, King TA. The predictive value of ductography and magnetic resonance imaging in the management of nipple discharge. Ann Surg Oncol. 2007 Dec;14(12):3369-77. doi: 10.1245/s10434-007-9530-5. Epub 2007 Sep 26.
Reference Type
BACKGROUND
Lubina N, Schedelbeck U, Roth A, Weng AM, Geissinger E, Honig A, Hahn D, Bley TA. 3.0 Tesla breast magnetic resonance imaging in patients with nipple discharge when mammography and ultrasound fail. Eur Radiol. 2015 May;25(5):1285-93. doi: 10.1007/s00330-014-3521-2. Epub 2014 Nov 30.
Reference Type
BACKGROUND
Nakahara H, Namba K, Watanabe R, Furusawa H, Matsu T, Akiyama F, Sakamoto G, Tamura S. A comparison of MR imaging, galactography and ultrasonography in patients with nipple discharge. Breast Cancer. 2003;10(4):320-9. doi: 10.1007/BF02967652.
Reference Type
BACKGROUND
van Gelder L, Bisschops RH, Menke-Pluymers MB, Westenend PJ, Plaisier PW. Magnetic resonance imaging in patients with unilateral bloody nipple discharge; useful when conventional diagnostics are negative? World J Surg. 2015 Jan;39(1):184-6. doi: 10.1007/s00268-014-2701-1.
Reference Type
BACKGROUND
Ballesio L, Maggi C, Savelli S, Angeletti M, De Felice C, Meggiorini ML, Manganaro L, Porfiri LM. Role of breast magnetic resonance imaging (MRI) in patients with unilateral nipple discharge: preliminary study. Radiol Med. 2008 Mar;113(2):249-64. doi: 10.1007/s11547-008-0245-x. Epub 2008 Apr 2. English, Italian.
Reference Type
BACKGROUND
Manganaro L, D'Ambrosio I, Gigli S, Di Pastena F, Giraldi G, Tardioli S, Framarino M, Porfiri LM, Ballesio L. Breast MRI in patients with unilateral bloody and serous-bloody nipple discharge: a comparison with galactography. Biomed Res Int. 2015;2015:806368. doi: 10.1155/2015/806368. Epub 2015 Jan 22.
Reference Type
BACKGROUND
Simmons R, Adamovich T, Brennan M, Christos P, Schultz M, Eisen C, Osborne M. Nonsurgical evaluation of pathologic nipple discharge. Ann Surg Oncol. 2003 Mar;10(2):113-6. doi: 10.1245/aso.2003.03.089.
Reference Type
BACKGROUND
Sakorafas GH. Nipple discharge: current diagnostic and therapeutic approaches. Cancer Treat Rev. 2001 Oct;27(5):275-82. doi: 10.1053/ctrv.2001.0234.
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00063806
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Molecular Breast Imaging in Patients With a History of Bloody Nipple Discharge
NCT00566280
COMPLETED
NA
Using Magnetic Resonance Spectroscopy With MRI to Non-invasively Determine Breast Cancer Extent of Disease
NCT00312637
WITHDRAWN
NA
Contrast-enhanced MR Imaging as a Breast Cancer Screening in Women at Intermediate Risk
NCT02210546
UNKNOWN
NA
The Significance of MRI in the Development of Diagnostics and Treatment of Breast Cancer
NCT01484704
UNKNOWN
Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants
NCT00474604
COMPLETED
NA
Novel MRI Sequence MR Fingerprinting in Breast MRI Feasibility Study
NCT03846947
COMPLETED
NA
MRI and Gene Expression in Diagnosing Patients With Ductal Breast Cancer In Situ
NCT02352883
ACTIVE_NOT_RECRUITING
NA
MRI to Detect Breast Tumors in Women
NCT00003302
COMPLETED
NA
Preoperative Assessment of Pathological Nipple Discharge With Delayed Ductal Imaging of Contrast-enhanced Mammography
NCT06033573
UNKNOWN
NA
Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients
NCT03303846
ACTIVE_NOT_RECRUITING
NA
Breast MRI for Newly Diagnosed Breast Cancer:Impact on Re-excision Lumpectomy
NCT01568346
TERMINATED
PHASE3
MRI for Detecting Cancer in Women Who Are at High Risk of Developing Breast Cancer
NCT00003736
COMPLETED
NA
Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening
NCT04877912
RECRUITING
Histologic Diagnoses of Incidentally Detected Lesions on MRI
NCT00579735
WITHDRAWN
DTi Diffusion Findings in Breast MRI Screening and Diagnostic
NCT03158441
WITHDRAWN
Evaluation of Magnetic Resonance Imaging (MRI) vs Molecular Breast Imaging (Tc-MBI) in Breast Cancer Patients
NCT02024074
TERMINATED
PHASE1
MRI Characterization of Mammographically Detected DCIS
NCT03495011
ACTIVE_NOT_RECRUITING
An Evaluation of Stereoscopic Digital Mammography for Earlier Detection of Breast Cancer and Reduced Rate of Recall
NCT00208871
COMPLETED
NA
MRI and Early Decision-making in Chemotherapy for Breast Cancer
NCT02449824
COMPLETED
Monitoring Response to Neoadjuvant Chemotherapy by the Use of Breast Proton MR Spectroscopy
NCT00580086
COMPLETED
A Study on Combined Low-pass Whole-genome and Methylome Testing of Bloody Nipple Discharge Specimens for Benign-Malignant Differentiation.
NCT07250204
NOT_YET_RECRUITING
3.0 Tesla Magnetic Resonance Imaging for Breast Cancer Detection in High Risk Women
NCT01409226
WITHDRAWN
NA
Feasibility Study of Vessel Analysis for Noninvasive Diagnosis of Malignancy in Breast Tumors
NCT00630292
TERMINATED
NA
FAST MRI Study in Breast Cancer Survivors
NCT02244593
COMPLETED
NA
The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy
NCT01749748
COMPLETED
NA