Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge

Contrast Enhanced Spectral Mammography (CESM) for the Evaluation of Pathologic Nipple Discharge: A Pilot Study

This clinical trial studies contrast enhanced spectral mammography (CESM) for the evaluation of pathologic nipple discharge. CESM is similar to standard mammography, but it includes an intravenous (by vein) injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. The goal of this trial is to learn if CESM, is better than standard mammography in quickly and efficiently determining the cause of nipple discharge and detecting breast cancer, if present. CESM may increase the chance of finding breast cancers and lower the risk of having unnecessary biopsies.

Study Overview

• Status: Recruiting
• Conditions: Breast Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Digital Tomosynthesis Mammography; Procedure: Contrast Enhanced Digital Mammography; Drug: Iodinated Contrast Agent

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the added sensitivity of contrast enhancement of CESM (represented by the subtracted contrast images of CESM) compared to low energy [LE] images of CESM (full field digital mammogram [FFDM] equivalent) in detecting the causative lesion (invasive malignancy, ductal carcinoma in situ [DCIS], atypia, or papilloma) in patients with pathologic nipple discharge (PND).

SECONDARY OBJECTIVES:

I. To compare the sensitivity, specificity, negative predictive value, and positive predictive value of CESM versus DBT and ultrasound (US) in predicting invasive malignancy or DCIS in patients with PND.

II. To compare the accuracy of digital breast tomosynthesis (DBT) and LE in the detection of invasive malignancy or DCIS, as well as in the detection of the causative lesion.

III. To estimate the proportion of cases in which CESM affects the choice of the lesion targeted for a biopsy with any imaging modality.

IV. To evaluate the cancer detection rate and the outcomes (need for additional imaging, biopsies, and final pathologic results) of incidental CESM findings.

EXPLORATORY OBJECTIVES:

I. To evaluate the correlation of blood biomarkers and the presence of invasive cancer and DCIS on pathology in the study patients.

II. To evaluate the role of the CESM enhancement pattern in choosing a precise target for a stereotactic biopsy.

III. To evaluate the effect of CESM on the patient workflow by calculating the time from presentation to the definitive diagnosis.

IV. To evaluate the technical feasibility of using CESM- guided or CESM directed biopsies.

V. In patients who undergo a CESM targeted or CESM directed biopsy we will evaluate the upgrade rate of DCIS to invasive malignancy or high-risk lesions to in-situ or invasive cancer for those patients who will require surgery as a part of their routine clinical care.

VI. In those study patients who undergo breast MRI as a part of their clinical care, the sensitivity and specificity of magnetic resonance imaging (MRI) and CESM for the detection of causative lesions will be compared.

OUTLINE:

Patients receive iodine-based contrast agent intravenously (IV) then undergo CESM over 10-15 minutes. Patients who have not undergone standard of care DBT within 3 months from the study, also undergo DBT.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olena Weaver, MD; Phone Number: 713-471-3613; Email: ooweaver@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Olena Weaver, MD; Phone Number: 713-471-3613; Email: ooweaver@mdanderson.org
      • Principal Investigator: Olena Weaver, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women presenting to MDACC for the evaluation of PND as the main or accompanying symptom
• Age 25-85 years
• Willing to participate in the study and undergo an IV placement, able to undergo iodinated contrast injection, and able to provide informed consent

Exclusion Criteria:

• Reported history of an allergic reaction to iodinated contrast
• History of anaphylactic reaction to any substance in the absence of a prior history of uneventful administration of iodine-based IV contrast.
• Renal insufficiency
• Pregnancy or lactation within 6 months
• Breast surgery affecting the symptomatic breast within prior 6 months, if it was located within 5 cm from the nipple
• Breast biopsy of the symptomatic breast within the last 2 months, if it was located within 5 cm from the nipple
• Breast MRI performed within 24 months before the patient presented with qualifying symptoms (MRI performed contemporarily with CEM for the evaluation of new symptoms is not an exclusion criterion).
• Known breast cancer or active inflammatory process (such as abscess or mastitis) in the breast of concern

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (CESM, DBT); Patients receive iodine-based contrast agent IV then undergo CESM over 10-15 minutes. Patients who have not undergone standard of care DBT within 3 months from the study, also undergo DBT.

Other: Questionnaire Administration; Ancillary studies; Procedure: Digital Tomosynthesis Mammography; Undergo DBT; Other Names: DBT; Digital Breast Tomosynthesis; Digital Tomosynthesis of the Breast; Procedure: Contrast Enhanced Digital Mammography; Undergo CESM; Other Names: Contrast Enhanced Spectral Mammography; Contrast Enhanced Mammography; CEDM; Contrast-Enhanced Digital Mammography; Drug: Iodinated Contrast Agent; Given iodine-based contrast agent IV; Other Names: Iodinated Contrast Dye; Iodine-containing Contrast Media

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of contrast enhancement of contrast enhanced spectral mammography (CESM)	Will be compared to low exposure (LE) images of CESM (full field digital mammogram equivalent) in detecting the causative lesion (invasive malignancy, ductal carcinoma in situ (DCIS), atypia, or papilloma) in patients with pathologic nipple discharge (PND).	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Olena Weaver, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Estimated): October 9, 2025
• Last Update Submitted That Met QC Criteria: October 7, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2021-0025 (Other Identifier: M D Anderson Cancer Center); NCI-2021-07594 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No