NCT05056844

Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 25 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2021-04-15
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2021-09-27
• Last updated: 2025-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study