Evidence map›Paper›PMID 35317766›Full record

ArticleBMC cancer2022

A multicenter prospective cohort study to evaluate feasibility of radio-frequency identification surgical guidance for nonpalpable breast lesions: design and rationale of the RFID Localizer 1 Trial.

Bianca M den Dekker, Anke Christenhusz, Thijs van Dalen, Lisa M Jongen, Margreet C van der Schaaf, Anneriet E Dassen, Ruud M Pijnappel

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Observational
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Bianca M den Dekker *Department of Radiology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands. bm.den.dekker@hotmail.com.
Anke Christenhusz *Department of Surgery, Medisch Spectrum Twente Enschede, University of Twente, Enschede, the Netherlands.
Thijs van DalenDepartment of Surgery, Diakonessenhuis Utrecht, Utrecht, the Netherlands.
Lisa M JongenDepartment of Radiology, Diakonessenhuis Utrecht, Utrecht, the Netherlands.
Margreet C van der SchaafDepartment of Radiology, Medisch Spectrum Twente Enschede, Enschede, the Netherlands.
Anneriet E DassenDepartment of Surgery, Medisch Spectrum Twente Enschede, University of Twente, Enschede, the Netherlands.
Ruud M PijnappelDepartment of Radiology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands.

Funding

Hologic Grand number 1257
6 · The paper itself

Abstract

backgroundBreast cancer screening and improving imaging techniques have led to an increase in the detection rate of early, nonpalpable breast cancers. For early breast cancer, breast conserving surgery is an effective and safe treatment. Accurate intraoperative lesion localization during breast conserving surgery is essential for adequate surgical margins while sparing surrounding healthy tissue to achieve optimal cosmesis. Preoperative wire localization and radioactive seed localization are accepted standard methods to guide surgical excision of nonpalpable breast lesions. However, these techniques present significant limitations. Radiofrequency identification (RFID) technology offers a new, nonradioactive method for localizing nonpalpable breast lesions in patients undergoing breast conserving surgery. This study aims to evaluate the feasibility of RFID surgical guidance for nonpalpable breast lesions.

methodsThis multicenter prospective cohort study was approved by the Institutional Review Board of the University Medical Center Utrecht. Written informed consent is obtained from all participants. Women with nonpalpable, histologically proven in situ or invasive breast cancer, who can undergo breast conserving surgery with RFID localization are considered eligible for participation. An RFID tag is placed under ultrasound guidance, up to 30 days preoperatively. The surgeon localizes the RFID tag with a radiofrequency reader that provides audible and visual real-time surgical guidance. The primary study outcome is the percentage of irradical excisions and reexcision rate, which will be compared to standards of the National Breast Cancer Organisation Netherlands (NABON)(≤ 15% irradical excisions of invasive carcinomas). Secondary outcomes include user acceptability/experiences, learning curve, duration and ease of the placement- and surgical procedure and adverse events. DISCUSSION: This study evaluates the feasibility of RFID surgical guidance for nonpalpable breast lesions. Results may have implications for the future localization techniques in women with nonpalpable breast cancer undergoing breast conserving surgery.

trial registrationNetherlands National Trial Register, NL8019 , registered on September 12

Indexed as

Radio Frequency Identification DeviceAdolescentAdultBreast NeoplasmsFeasibility StudiesFemaleHumansMargins of ExcisionMastectomy, SegmentalProspective StudiesYoung AdultBreast cancerBreast conserving surgeryLocalizationRadiofrequency identificationRFID

Identifiers

PMID35317766
PMCPMC8939217

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