Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge

NCT ID: NCT05056844

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2027-04-30

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the added sensitivity of contrast enhancement of CESM (represented by the subtracted contrast images of CESM) compared to low energy [LE] images of CESM (full field digital mammogram [FFDM] equivalent) in detecting the causative lesion (invasive malignancy, ductal carcinoma in situ [DCIS], atypia, or papilloma) in patients with pathologic nipple discharge (PND).

SECONDARY OBJECTIVES:

I. To compare the sensitivity, specificity, negative predictive value, and positive predictive value of CESM versus DBT and ultrasound (US) in predicting invasive malignancy or DCIS in patients with PND.

II. To compare the accuracy of digital breast tomosynthesis (DBT) and LE in the detection of invasive malignancy or DCIS, as well as in the detection of the causative lesion.

III. To estimate the proportion of cases in which CESM affects the choice of the lesion targeted for a biopsy with any imaging modality.

IV. To evaluate the cancer detection rate and the outcomes (need for additional imaging, biopsies, and final pathologic results) of incidental CESM findings.

EXPLORATORY OBJECTIVES:

I. To evaluate the correlation of blood biomarkers and the presence of invasive cancer and DCIS on pathology in the study patients.

II. To evaluate the role of the CESM enhancement pattern in choosing a precise target for a stereotactic biopsy.

III. To evaluate the effect of CESM on the patient workflow by calculating the time from presentation to the definitive diagnosis.

IV. To evaluate the technical feasibility of using CESM- guided or CESM directed biopsies.

V. In patients who undergo a CESM targeted or CESM directed biopsy we will evaluate the upgrade rate of DCIS to invasive malignancy or high-risk lesions to in-situ or invasive cancer for those patients who will require surgery as a part of their routine clinical care.

VI. In those study patients who undergo breast MRI as a part of their clinical care, the sensitivity and specificity of magnetic resonance imaging (MRI) and CESM for the detection of causative lesions will be compared.

OUTLINE:

Patients receive iodine-based contrast agent intravenously (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.

Conditions

Breast Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Contrast Enhanced Digital Mammography

Intervention Type: PROCEDURE

Undergo CESM

Digital Tomosynthesis Mammography

Intervention Type: PROCEDURE

Undergo DBT

Iodinated Contrast Agent

Intervention Type: DRUG

Given iodine-based contrast agent IV

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Contrast Enhanced Digital Mammography

Undergo CESM

Intervention Type: PROCEDURE

Digital Tomosynthesis Mammography

Undergo DBT

Intervention Type: PROCEDURE

Iodinated Contrast Agent

Given iodine-based contrast agent IV

Intervention Type: DRUG

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

CEDM; Contrast Enhanced Spectral Mammography; Contrast-Enhanced Digital Mammography; Contrast Enhanced Mammography; DBT; Digital Breast Tomosynthesis; Digital Tomosynthesis of the Breast; Iodinated Contrast Dye; Iodine-containing Contrast Media

Eligibility Criteria

Inclusion 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olena Weaver, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Olena Weaver, MD

Role: CONTACT

ooweaver@mdanderson.org

713-471-3613

Facility Contacts

Olena Weaver, MD

Role: primary

ooweaver@mdanderson.org

713-471-3613

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

NCI-2021-07594

Identifier Type: REGISTRY

Identifier Source: secondary_id

2021-0025

Identifier Type: OTHER

Identifier Source: secondary_id

2021-0025

Identifier Type: -

Identifier Source: org_study_id