Clinical trial · Interventional
Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
NCT04397185CI-TRIAL-00101187completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This prospective, multicenter, 1:1 randomized, controlled trial is designed to evaluate the safety and effectiveness of the Breast Cancer Locator (BCL) in subjects with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS). Subjects will be randomized to breast conserving surgery (BCS) utilizing either the BCL or wire localization (WL) to guide surgery.
Conditions
Conditions (1)
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 Female | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Cancer Locator (BCL) guided partial mastectomy | Device | — | UNRESOLVED |
| Wire Localized (WL) partial mastectomy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Breast Cancer Locator (BCL)
- description
- Subject randomized to BCL surgical guidance to perform partial mastectomy
- interventionNames
- Device: Breast Cancer Locator (BCL) guided partial mastectomy
- type
- ACTIVE_COMPARATOR
- label
- Wire Localization (WL)
- description
- Subject randomized to WL surgical guidance to perform partial mastectomy
- interventionNames
- Device: Wire Localized (WL) partial mastectomy
Primary outcomes (1)
- measure
- Positive margin rate
- timeFrame
- At completion of study recruitment, approximately 18 months after first subject enrolled
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female gender * Age \> 18 years * Histologic diagnosis of invasive breast cancer or DCIS * The surgeon determines that pre-operative tumor localization is required because the tumor cannot be definitively detected by palpation * The tumor is unifocal or multifocal with satellite lesions \< or = 2 cm from primary tumor * The tumor enhances on prone breast MRI imaging * The tumor is ≥ 1 cm in diameter on prone breast MRI * Subject and surgeon agree to perform BCS * Subject voluntarily provides informed consent Exclusion Criteria: * Absolute contraindication to MRI, including presence of implanted electrical device (e.g., pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes * Severe claustrophobia that precludes prone or supine MRI * Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy * Compromised renal function including chronic, severe kidney disease (GFR \< 30 ml/min/1.73m2), or acute kidney injury * Pregnancy - In women of childbearing potential, a urine pregnancy test will be performed * Subjects who have received or plan to receive neoadjuvant chemotherapy * Sternal notch to nipple distance of \> 32 cm as measured in a sitting or standing position * Measurement of widest circumference around breasts and arms \> 135 cm for sites using 60cm bore scanners, and measurement of widest circumference around breasts and arms \>145 cm for sites using 70 cm bore scanners * Subjects with known allergy to materials present in the device * Use of localization with devices other than a localization wire, including intraoperative ultrasound guidance, radiofrequency emitting implants, magnetic seeds, radioactive seeds, and tissue inspection devices (MarginProbe) * Subject would require \> 2 localization wires, if randomized to standard of care * Subjects with multicentric tumors (additional tumors \> 2 cm from primary) * Subject would require chest wall muscle nerve block as part of the operation
References
Publications (0)
Data not yet available
No reference posted for this study.