Clinical trial · Observational
Contrast-Enhanced Stereotactic Biopsy
Assessing the Optimal Amount of Tissue Sampling in Contrast-Enhanced Stereotactic Biopsy (CESB)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Female | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast Enhanced Stereotactic Biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with 'recombined imaging only lesions' or ROLs
- description
- 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.
- interventionNames
- Diagnostic Test: Contrast Enhanced Stereotactic Biopsy
Primary outcomes (1)
- measure
- Amount of tissue needed for CESB
- timeFrame
- 2 years
- description
- The investigators calculate the diagnostic yield per biopsy sample to establish to minimum amount of tissue samples needed for CESB
Secondary outcomes (3)
- measure
- Complication rate
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available