An interventional study of RFID Localization and Wire Localization in Breast Tumor, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-25.
Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Other
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.
As part of standard of care, participants will receive: an ultrasound (US) or mammographic guided localization; excisional breast surgery; and a follow-up visit in breast surgery clinic.
As part of the research protocol, participants will receive a RFID chip for the localization procedure and complete surveys.
Part A of this project is for physician training to master the technique of RFID placement and retrieval. On the day of surgery prior to going to the operating room, all participants will have the RFID placed first to allow radiologists to become familiar with placement of the RFID localizer. Participants will then immediately undergo wire localization. Either ultrasound or mammogram guidance will be used for the localization at the discretion of the performing radiologist. Surgeons will use a reader to locate the RFID chip during surgery. The wire will be present in the event the area of concern cannot be adequately located with the reader. Participants, radiologists, surgeons, breast surgery and radiology staff will complete surveys.
Part B of this project is a prospective trial to examine safety, efficacy, operating room utilization patterns, and satisfaction with RFID versus wire localization. Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). Participants will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care. Participants, radiologists, surgeons, breast surgery and radiology staff will complete surveys.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 38 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Part A of this project is for physician training to master the technique of RFID placement and retrieval. On the day of surgery prior to going to the operating room, all participants will have the RFID placed first to allow radiologists to become familiar with placement of the RFID localizer. Participants will then immediately undergo wire localization. Either ultrasound or mammogram guidance will be used for the localization at the discretion of the performing radiologist. Surgeons will use a reader to locate the RFID chip during surgery. The wire will be present in the event the area of concern cannot be adequately located with the reader.
Device: RFID and Wire Localization
Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care.
Device: RFID Localization
Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care.
Device: Wire Localization
The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.
The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.
Both RFID and the standard of care wire localization will be performed for physician training.
Number of Participants With Successful Localization
Whether the surgeon was able to identify and remove the tumor
Time frame: From the date of localization through the date of surgery up to 4 weeks; data collected during Visit 3 at time of surgery
Surveys of Satisfaction: Participant
Survey Question: "Compared to expected, how uncomfortable was the localization?" Scored on a scale of 1 to 5 with the best being 5
Time frame: Data collected during date of localization at Visit 2, up to approximately one month from baseline visit
Surveys of Satisfaction
Surveys of Radiology Nurse ease of scheduling the localization procedure. Scored on a scale of 1 to 5 with the best being 5
Time frame: Data collected at baseline during Visit 1
Surveys of Satisfaction
Surveys of radiologist satisfaction with the localization procedure. Scored on a scale of 1 to 5 with the best being 5
Time frame: Data collected during date of localization at Visit 2, up to approximately one month from baseline visit
Number of Participants With Tumor Incompletely Excised
Number of participants with positive margin on pathology
Time frame: Surgical resection specimen collected during Visit 3, at time of surgery
| Milestone | RFID and Wire Localization | RFID Localization | Wire Localization |
|---|---|---|---|
| Started | 10 | 16 | 12 |
| Completed | 9 | 15 | 12 |
| Not completed | 1 | 1 | 0 |
Whether the surgeon was able to identify and remove the tumor
| Participants | RFID and Wire Localization | RFID Localization | Wire Localization |
|---|---|---|---|
| Number of Participants With Successful Localization | 9 | 15 | 12 |
Survey Question: "Compared to expected, how uncomfortable was the localization?" Scored on a scale of 1 to 5 with the best being 5
| score on a scale | RFID and Wire Localization | RFID Localization | Wire Localization |
|---|---|---|---|
| Surveys of Satisfaction: Participant | 3.4 ± 0.72 | 3.7 ± 0.85 | 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
| score on a scale | RFID and Wire Localization | RFID Localization | Wire Localization |
|---|---|---|---|
| Surveys of Satisfaction | — | 4 ± 0.51 | 4 ± 1.22 |
Surveys of radiologist satisfaction with the localization procedure. Scored on a scale of 1 to 5 with the best being 5
| score on a scale | RFID and Wire Localization | RFID Localization | Wire Localization |
|---|---|---|---|
| Surveys of Satisfaction | — | 4 ± 1.28 | 5 ± 1.21 |
Number of participants with positive margin on pathology
| Participants | RFID and Wire Localization | RFID Localization | Wire Localization |
|---|---|---|---|
| Number of Participants With Tumor Incompletely Excised | 0 | 0 | 0 |
Collected over From localization up to surgery, up to 4 weeks, and following surgery, a maximum of 39 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RFID and Wire Localization | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| RFID Localization | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Wire Localization | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | RFID and Wire Localization | RFID Localization | Wire Localization | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 12 | 7 | 26 |
| >=65 years | 2 | 3 | 5 | 10 |
| Sex: Female, Male(Participants) | RFID and Wire Localization | RFID Localization | Wire Localization | Total |
|---|---|---|---|---|
| Female | 9 | 15 | 12 | 36 |
| Male | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | RFID and Wire Localization | RFID Localization | Wire Localization | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 1 |
| White | 9 | 14 | 12 | 35 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
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University of Missouri-Columbia