Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge

Not Applicable

Recruiting

• Conditions: Breast Carcinoma
• Interventions: Procedure: Contrast Enhanced Digital Mammography; Procedure: Digital Tomosynthesis Mammography; Drug: Iodinated Contrast Agent; Other: Questionnaire Administration

• Registration Number: NCT05056844
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-04-15
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-25
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 66

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (CESM, DBT)	Contrast Enhanced Digital Mammography	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.
Diagnostic (CESM, DBT)	Digital Tomosynthesis Mammography	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.
Diagnostic (CESM, DBT)	Iodinated Contrast Agent	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.
Diagnostic (CESM, DBT)	Questionnaire Administration	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 Measures

Name	Time	Method
Sensitivity of contrast enhancement of contrast enhanced spectral mammography (CESM)	through study completion, an average of 1 year	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).

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States