Actively Recruiting

Phase Not Applicable
Age: 25Years - 85Years
FEMALE
NCT05056844

Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge

Led by M.D. Anderson Cancer Center · Updated on 2025-10-09

66

Participants Needed

1

Research Sites

315 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge

Who Can Participate

Age: 25Years - 85Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women presenting to MDACC for the evaluation of pathologic nipple discharge as the main or accompanying symptom
  • Age between 25 and 85 years
  • Willing to participate and undergo IV placement
  • Able to receive iodinated contrast injection
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • History of allergic reaction to iodinated contrast
  • History of anaphylactic reaction to any substance without prior uneventful iodine-based contrast administration
  • Renal insufficiency
  • Pregnancy or lactation within the last 6 months
  • Breast surgery on the symptomatic breast within 6 months if located within 5 cm from the nipple
  • Breast biopsy on the symptomatic breast within the last 2 months if located within 5 cm from the nipple
  • Breast MRI within 24 months before presenting with symptoms (except MRI done contemporarily with CESM for new symptoms)
  • Known breast cancer or active inflammatory breast condition (abscess or mastitis) in the breast of concern

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

O

Olena Weaver, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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