Contrast-Enhanced Stereotactic Biopsy

Recruiting

• Conditions: Breast Neoplasms; Breast Cancer Female; Breast Cancer
• Interventions: Diagnostic Test: Contrast Enhanced Stereotactic Biopsy

• Registration Number: NCT06062992
• Lead Sponsor: Zuyderland Medisch Centrum

Brief 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.

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 Timeline

• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-09-25
• Study First Posted: 2023-10-02
• Study Start: 2023-10-13
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-08
• Primary Completion: 2025-10-15
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with 'recombined imaging only lesions' or ROLs	Contrast Enhanced Stereotactic Biopsy	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.

Primary Outcome Measures

Name	Time	Method
Amount of tissue needed for CESB	2 years	The investigators calculate the diagnostic yield per biopsy sample to establish to minimum amount of tissue samples needed for CESB

Secondary Outcome Measures

Name	Time	Method
Patient comfort	2 years	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)
Complication rate	2 years	The investigators will establish the complication rate of CESB (for example: hematoma, technical failures, infection)
Diagnostic results	2 years	The investigators will establish the various diagnostic outcomes (pathology results) of the biopsies performed using CESB

Trial Locations

Locations (1)

Zuyderland Medical Center; 🇳🇱 Sittard, Limburg, Netherlands