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Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge

NCT05056844 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-10-09

No results posted yet for this study

Summary

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.

Conditions

  • Breast Carcinoma

Interventions

PROCEDURE

Contrast Enhanced Digital Mammography

Undergo CESM

PROCEDURE

Digital Tomosynthesis Mammography

Undergo DBT

DRUG

Iodinated Contrast Agent

Given iodine-based contrast agent IV

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Olena Weaver, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05056844 on ClinicalTrials.gov