Clinical trial · Interventional
Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy
A Feasibility Study of Radiofrequency Identification (RFID) Localization of Breast Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient resources
Summary
Brief summary (as posted)
This pilot clinical trial studies the use of the radiofrequency-guided localization in patients with abnormal breast tissue undergoing lumpectomy (a type of breast-sparing surgery). The radiofrequency identification localization system consists of an implantable radiofrequency identification tag and a hand-held radiofrequency reader to mark abnormal breast tissue before surgery and later surgically retrieve them. Radiofrequency-guided localization may make it easier to find and remove abnormal breast tissue during lumpectomy.
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 Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lumpectomy | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Radiofrequency-Guided Localization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (radiofrequency-guided localization)
- description
- Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.
- interventionNames
- Procedure: Lumpectomy
- Other: Questionnaire Administration
- Procedure: Radiofrequency-Guided Localization
Primary outcomes (1)
- measure
- Localization success, defined as the surgical target visualized in the removed specimen AND the RFID tag removed from the patient's breast
- timeFrame
- At time of surgery
- description
- Will be summarized using descriptive statistics, including total numbers, percentages, means, and proportions.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have had stereotactic or ultrasound-guided biopsy with marker placement * Have a lesion or biopsy marker that is visible under ultrasound * Have a surgical target =\< 6 cm from the skin when lying supine * Have a discreet surgical target * Have a lesion in which the center/focal area is defined * Have the ability to understand and the willingness to sign a written informed consent document * Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status will not be used as an inclusion criterion * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Require more than one localization needle for localization of the surgical target (bracket localization) * Have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast * Have a prosthesis/implant in the operative breast * Have a cardiac pacemaker or defibrillator device * Be contraindicated for surgery * Be pregnant
References
Publications (0)
Data not yet available