Contrast-Enhanced Stereotactic Biopsy

Breast Cancer Clinical Trial

— CESB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062992
• Other study ID #: ZuyderlandMC_CESB
• Status: Recruiting
• Start date: October 13, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2024
• Source: Zuyderland Medisch Centrum
• Contact: Marc Lobbes, MD, PhD
• Phone: +31884597777
• Email: m.lobbes[@]zuyderland.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 1, 2026
• Est. primary completion date: October 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Neoplasms

Intervention

Diagnostic Test:
• Contrast Enhanced Stereotactic Biopsy
Stereotactic breast biopsy using CEM as targeting modality

Locations

Country	Name	City	State
Netherlands	Zuyderland Medical Center	Sittard	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum	Hologic, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complication rate	The investigators will establish the complication rate of CESB (for example: hematoma, technical failures, infection)	2 years
Secondary	Diagnostic results	The investigators will establish the various diagnostic outcomes (pathology results) of the biopsies performed using CESB	2 years
Secondary	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