Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05056844
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
25 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Contrast Enhanced Digital Mammography — PROCEDURE
    Undergo CESM
  • Digital Tomosynthesis Mammography — PROCEDURE
    Undergo DBT
  • Iodinated Contrast Agent — DRUG
    Given iodine-based contrast agent IV
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Apr 15, 2021
Status verified
Oct 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
66 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Sensitivity of contrast enhancement of contrast enhanced spectral mammography (CESM) [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Olena Weaver, MD
[email protected]
713-471-3613
Olena Weaver, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
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By specialty
OncologyBreast oncologyWomen's health
By research site
M D Anderson Cancer Center· Houston, TX

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