Contrast-Enhanced Stereotactic Biopsy

NCT06062992 | Completed FDA Device

• 1 other identifier: ZuyderlandMC_CESB
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Neoplasms; Breast Cancer Female

Keywords

Breast cancer; Mammography; CEM; Biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Complication rate

  2 years

• Diagnostic results

  2 years

• Patient comfort

  2 years

Study Arms (1)

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

Interventions

Contrast Enhanced Stereotactic Biopsy DIAGNOSTIC_TEST

Stereotactic breast biopsy using CEM as targeting modality

Patients with 'recombined imaging only lesions' or ROLs

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead
• Hologic, Inc.: collaborator

Study Sites (1)

Zuyderland Medical Center

Sittard, Limburg, 6162BG, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vacuum assisted large core needle biopsies of the breast

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 2, 2023
• Study Start: October 13, 2023
• Primary Completion: February 15, 2026
• Study Completion: February 16, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 2 years
• Access Criteria: Signed agreement between institutes

Locations

NL (1)