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Contrast-Enhanced Stereotactic Biopsy

NCT06062992 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 77

Last updated 2026-02-27

No results posted yet for this study

Summary

Contrast-enhanced mammography (CEM) is an emerging breast imaging modality that is based on dual-energy mammography and the injection of iodinated contrast agent. A typical CEM study consists of a low-energy image (equal to a FFDM image) and a recombined image (in which areas of contrast enhancement can be appreciated). However, the situation can occur that lesions are visible only on the recombined (contrast) images (in this protocol defined as 'recombined-only lesions' or ROLs). In these cases, radiologists need to perform 'contrast-enhanced stereotactic biopsy' (CESB), in which CEM is used as a targeting modality.

However, experiences with CESB are still limited and one of the most urgent questions that need to be answered is the amount of tissue sampling that is required to reach a final diagnosis. The investigators aim to study where the cut off will be in terms of tissue sampling volume needed (i.e., number of biopsies) for a reliable diagnosis.

Conditions

Interventions

DIAGNOSTIC_TEST

Contrast Enhanced Stereotactic Biopsy

Stereotactic breast biopsy using CEM as targeting modality

Sponsors & Collaborators

  • Hologic, Inc.

    collaborator INDUSTRY

  • Zuyderland Medisch Centrum

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-13
Primary Completion
2026-02-15
Completion
2026-02-16
FDA Device
Yes

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06062992 on ClinicalTrials.gov