Clinical trial · Interventional
Study to Demonstrate the Preliminary Safety and Effectiveness of IPBS in Performing MRI-Guided Targeting and Intervention of Breast Tissue in Female Patients Indicated for MRI-Guided Breast Biopsy
A Prospective, Open-Label, Single-Arm, Single-Site, Study to Demonstrate the Preliminary Safety and Effectiveness of IPBS in Performing MRI-Guided Targeting and Intervention of Breast Tissue in Female Patients Indicated for MRI-Guided Breast Biopsy.
- 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)
A preliminary demonstration of the Safety of IPBS in positioning a vacuum assisted biopsy (VAB) tool to enable an MRI-guided automated breast biopsy. This will consist of 10-15 biopsy procedures facilitated by the MRI-guided system. Patients will be followed after the procedure to assess clinical outcomes.
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 Diagnosis | — | UNRESOLVED | — |
| Breast Cancer Screening | — | UNRESOLVED | — |
| MRI Guided Breast Biopsy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IPBS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IPBS
- interventionNames
- Device: IPBS
Primary outcomes (1)
- measure
- Frequency of target reached by the interventional tools as determined by a qualified physician reviewing the MR images.
- timeFrame
- Day 1
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients over the age of 18 with suspected or confirmed breast cancer requiring a manual MRI-guided breast biopsy for diagnosis and staging. * Individuals Capable of giving a free and informed consent. Exclusion Criteria: * Any patient for whom the manual MRI-guided breast biopsy procedure would not be possible (size of patient, etc.). * Patients who refuse the procedure for any reason will be excluded from the study at the investigators discretion. * Patients who are not suitable for the procedure will be excluded at the investigators discretion. * Patients unwilling to complete associated study questionnaires or follow up visits. * Women who are pregnant or who plan to become pregnant within the study duration.
References
Publications (0)
Data not yet available