Contrast-Enhanced Stereotactic Biopsy (CESB)

Assessing the Optimal Amount of Tissue Sampling in Contrast-Enhanced Stereotactic Biopsy (CESB)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Neoplasms; Breast Cancer Female
• Intervention / Treatment: Diagnostic test: Contrast Enhanced Stereotactic Biopsy

Detailed Description

Rationale: 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.

Objective: To determine the minimum number of CESB-guided tissue samples needed to establish a final histopathological biopsy diagnosis for ROLs.

Study design: Prospective, single center, observational cohort study. Study population: Non-pregnant women (>18 years) able to provide written informed consent and with a ROL recently observed during a regular CEM examination.

Intervention: Included subject will undergo CESB, consisting of an intravenous injection of iodinated contrast agent prior to image acquisition. After administration, a contrast-enhanced stereotactic localization will be performed of the ROL to determine the location and depth of the lesion within the breast. After targeting, 18 samples will be acquired using a 9 Gauge vacuum-assistend biopsy (VAB), collected in six separate and numbered cassettes, to be able to determine the chronological order of the tissue sampling. Each specimen will be histologically analyzed in this chronological order and findings will be compared with the final histopathological result after assessment of all 18 specimens.

Main study parameters/endpoints: The primary study aim will be to calculate the cumulative diagnostic yield per specimen, enabling us to define a minimum number of biopsies required (or tissue volume needed) to establish a reliable diagnosis using CESB. Secondary study outcomes will be general parameters of the biopsy procedure itself, such as patient characteristics, histopathological results, pain experienced during the procedure, and complication rates (hematoma, infection).

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Sittard, Limburg, Netherlands, 6162BG
      • Zuyderland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All women recently underwent CEM in our hospital, showing a ROL. Common indications to perform a CEM examination in our hospital are: recalls from breast cancer screening, as problem-solving tool after inconclusive FFDM and/or ultrasound, breast MRI alternative, preoperative staging of breast cancer and baseline examination for women treated with neoadjuvant systemic therapy (where CEM will be used as response monitoring tool).

Description

Inclusion Criteria:

• Women >18 years of age;
• Recent detection of a ROL on CEM;
• Able to provide written informed consent.

Exclusion Criteria:

• All men (male sex);
• Women (female sex) who are contra indicated for CESB (for example: impaired renal function, known hypersensitivity to iodinated contrast);
• Pregnant women.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with 'recombined imaging only lesions' or ROLs; Women that recently underwent CEM, which showed a suspicious breast lesion only on the recombined (enhancement) images: a 'recombined image only lesions' or ROL. These women are indicated to undergo CESB.	Diagnostic test: Contrast Enhanced Stereotactic Biopsy; Stereotactic breast biopsy using CEM as targeting modality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of tissue needed for CESB	The investigators calculate the diagnostic yield per biopsy sample to establish to minimum amount of tissue samples needed for CESB	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	The investigators will establish the complication rate of CESB (for example: hematoma, technical failures, infection)	2 years
Diagnostic results	The investigators will establish the various diagnostic outcomes (pathology results) of the biopsies performed using CESB	2 years
Patient comfort	The investigators will establish the patient (dis)comfort of CESB by scoring the pain associated with this intervention on a 0-10 scale (0 no pain, 10 worst pain ever)	2 years

Collaborators and Investigators

• Sponsor: Zuyderland Medisch Centrum
• Collaborators: Hologic, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Actual): February 15, 2026
• Study Completion (Actual): February 16, 2026

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Breast cancer; Biopsy; Mammography; CEM
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: ZuyderlandMC_CESB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data can be made available to other researchers.
• IPD Sharing Time Frame: 2 years
• IPD Sharing Access Criteria: Signed agreement between institutes
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No