Contrast-Enhanced Stereotactic Biopsy

Trial Title: Contrast-Enhanced Stereotactic Biopsy

NCT ID: NCT06062992

Condition: Breast Cancer
Breast Neoplasms
Breast Cancer Female

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Breast cancer
Mammography
CEM
Biopsy

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Contrast Enhanced Stereotactic Biopsy
Description: Stereotactic breast biopsy using CEM as targeting modality
Arm group label: Patients with 'recombined imaging only lesions' or ROLs

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).

Criteria for eligibility:

Study pop:
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).

Sampling method: Non-Probability Sample
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.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Zuyderland Medical Center

Address:
City: Sittard
Zip: 6162BG
Country: Netherlands

Status: Recruiting

Contact:
Last name: Marc Lobbes, MD, PhD

Phone: +31884597777
Email: m.lobbes@zuyderland.nl

Start date: October 13, 2023

Completion date: March 1, 2026

Lead sponsor:
Agency: Zuyderland Medisch Centrum
Agency class: Other

Collaborator:
Agency: Hologic, Inc.
Agency class: Industry

Source: Zuyderland Medisch Centrum

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06062992