Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge

Condition
Breast Carcinoma
Intervention / Treatment

-

Contacts and Locations

Houston

M D Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

25 Years to 85 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Olena Weaver, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2025-04-30