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Radiofrequency Chip for Localization of Non-Palpable Breast Lesions
NA trial testing RFID Localization in Breast Tumor in 38 participants. Completed in 19 April 2021.
| Lead sponsor | University of Missouri-Columbia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 38 |
| Start date | 18 October 2018 |
| Primary completion | 19 April 2021 |
| Estimated completion | 19 April 2021 |
| Sites | 1 location across United States |
University of Missouri-Columbia
18 and older, female only, with Breast Tumor. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Whether the surgeon was able to identify and remove the tumor
| Group | Value | 95% CI |
|---|---|---|
| RFID and Wire Localization | 9 | |
| RFID Localization | 15 | |
| Wire Localization | 12 |
Survey Question: "Compared to expected, how uncomfortable was the localization?" Scored on a scale of 1 to 5 with the best being 5
| Group | Value | 95% CI |
|---|---|---|
| RFID and Wire Localization | 3.4 | ± 0.72 |
| RFID Localization | 3.7 | ± 0.85 |
| Wire Localization | 4.4 | ± 0.81 |
Surveys of Radiology Nurse ease of scheduling the localization procedure. Scored on a scale of 1 to 5 with the best being 5
| Group | Value | 95% CI |
|---|---|---|
| RFID Localization | 4 | ± 0.51 |
| Wire Localization | 4 | ± 1.22 |
Surveys of radiologist satisfaction with the localization procedure. Scored on a scale of 1 to 5 with the best being 5
| Group | Value | 95% CI |
|---|---|---|
| RFID Localization | 4 | ± 1.28 |
| Wire Localization | 5 | ± 1.21 |
Number of participants with positive margin on pathology
| Group | Value | 95% CI |
|---|---|---|
| RFID and Wire Localization | 0 | |
| RFID Localization | 0 | |
| Wire Localization | 0 |
The purpose of the project is to compare Radiofrequency identification device (RFID) localization technique with the current clinical standard wire localization technique. The Investigator's hypotheses is that the RFID localization technique is non-inferior to wire localization for breast lesions (tumors). The study will be conducted in two parts. The purpose of Part A is for physician training with the RFID device. Nine subjects will undergo RFID and wire localization prior to breast lesion excision. This will allow the breast radiologists and surgeons to become comfortable with RFID device placement and retrieval. Additionally, the investigators will pilot the data collection surveys and chart review methodology to be used in Part B. The purpose of Part B is to conduct a randomized clinical trial to assess whether RFID localization is non-inferior to wire localization for breast lesions. For this part, sixty subjects will be randomized to RFID (N=30) or wire localization (N=30) at time of enrollment. Surveys will be used to gather data from participants, radiologists, surgeons, and technologists/mammography nurses. A variety of data will be collected including, but not limited to, information on tumor size, location, depth; subject demographics; adequacy of tumor margins, re-excision rates, accuracy of wire or chip placement, and surgical complications.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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