Clinical trial NCT06062992: Contrast-Enhanced Stereotactic Biopsy
Official title: Assessing the Optimal Amount of Tissue Sampling in Contrast-Enhanced Stereotactic Biopsy (CESB)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Breast Neoplasms
Breast Cancer Female
Keywords: Breast cancer
Mammography
CEM
Biopsy
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
Collaborators: name: Hologic, Inc.
First posted: 2023-10-02
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Amount of tissue needed for CESB
timeFrame: 2 years
Secondary outcomes:
measure: Complication rate
timeFrame: 2 years
measure: Diagnostic results
timeFrame: 2 years
measure: Patient comfort
timeFrame: 2 years
Other outcomes:
Locations:
city: Sittard
country: Netherlands
facility: Zuyderland Medical Center
state: Limburg
Study officials:
References: