Clinical trial · Interventional
A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers
NCT03573661CI-TRIAL-00051974BCLcompletedN/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)
The project objective is to determine whether the Breast Cancer Locator (BCL) can safely and effectively localize breast cancers in patients treated at locations distant from the site of BCL manufacture. This information will be transmitted to CairnSurgical, Inc. where the BCL will be fabricated, tested for quality assurance, sterilized and shipped to the patient's surgeon. The surgeon will then utilize the BCL at the time of resection of the palpable breast cancer.
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 |
|---|---|---|---|
| Palpable Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Cancer Locator (BCL) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast Cancer Locator (BCL)
- description
- The Breast Cancer Locator (BCL) uses 3D printing to create a bra-like plastic form that matches the breast surface when the patient is in the supine MRI (and surgical) position. This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of procedure.
- interventionNames
- Device: Breast Cancer Locator (BCL)
Primary outcomes (1)
- measure
- The proportion of patients who had the localization wire placed within the cancer on the specimen mammogram
- timeFrame
- Within approximately 60 Days post-surgery (all measures are collected by the time of patient follow-up visit within approximately 60 days after surgery, and recorded by the surgeon and radiologist in Case Report Forms (CRF forms).
- description
- Yes/No answer from Radiologist. Final measure will be % of cases rated Yes (wire deployed within the cancer on specimen mammogram).
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \> 18 years. 2. Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ. 3. Patient desire to undergo breast surgery (lumpectomy or non-skin sparing mastectomy). 4. Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted. 5. The cancer enhances on prone breast MRI imaging 6. The cancer is visible on mammography. Exclusion Criteria: 1. Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes. 2. Severe claustrophobia. 3. Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (creatinine \> 2.0). 4. History of median sternotomy. 5. Pregnancy. Patient attestation that they are not pregnant will be acceptable. 6. Patients receiving neoadjuvant chemotherapy.
References
Publications (0)
Data not yet available
No reference posted for this study.