Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge

NCT05056844 | Recruiting FDA Device

• 2 other identifiers: 2021-0025NCI-2021-07594
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Diagnostic (CESM, DBT)

EXPERIMENTAL

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.

Procedure: Contrast Enhanced Digital Mammography; Procedure: Digital Tomosynthesis Mammography; Drug: Iodinated Contrast Agent; Other: Questionnaire Administration

Interventions

Contrast Enhanced Digital Mammography PROCEDURE

Undergo CESM

Also known as: CEDM, Contrast Enhanced Spectral Mammography, Contrast-Enhanced Digital Mammography, Contrast Enhanced Mammography

Diagnostic (CESM, DBT)

Digital Tomosynthesis Mammography PROCEDURE

Undergo DBT

Also known as: DBT, Digital Breast Tomosynthesis, Digital Tomosynthesis of the Breast

Diagnostic (CESM, DBT)

Iodinated Contrast Agent DRUG

Given iodine-based contrast agent IV

Also known as: Iodinated Contrast Dye, Iodine-containing Contrast Media

Diagnostic (CESM, DBT)

Questionnaire Administration OTHER

Ancillary studies

Diagnostic (CESM, DBT)

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Known breast cancer or active inflammatory process (such as abscess or mastitis) in the breast of concern

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Olena Weaver, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olena Weaver, MD

CONTACT

713-471-3613; ooweaver@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 27, 2021
• Study Start: April 15, 2021
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 9, 2025

Record last verified: 2025-10

Locations

US (1)