RFID localization for nonpalpable breast lesions is a feasible, non-radioactive alternative for I125-seed localization with regard to the percentage of radical excisions (radical, focally irradical, more than focally irradical) and re-excision rate.
ID
Bron
Verkorte titel
Aandoening
Breast cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary endpoint of the study is the percentage radical excisions. Margins are classified as tumor free, focally irradical and (more than focally) irradical, see figure below. Both focally irradical and more than focally irradical excisons are considered irradical excisions. The percentage of re-excisions following irradical excisions is recorded.
Achtergrond van het onderzoek
Rationale: Breast conserving surgery is an effective and safe method to treat early breast cancer. Accurate intraoperative lesion localization is essential to remove the lesion with adequate surgical margins and to avoid unnecessary resection of healthy tissue in order to provide a good cosmetic result without compromising survival or local recurrence. Preoperative wire localization and radioactive seed localization are accepted standard methods to guide surgical excision of nonpalpable breast lesions. However, these techniques present a number of limitations. Radiofrequency technology may offer a viable alternative method for localizing nonpalpable breast lesions in patients undergoing breast surgery.
Objective: To demonstrate feasibility of RFID surgical guidance for nonpalpable breast lesions with regard to percentage radical excisions and re-excision rate.
Study design: Multicenter prospective cohort study.
Study population: University Medical Center / Diakonessenhuis Utrecht: ≥100 women, ≥ 18 year old, with a nonpalpable histologically proven in situ or invasive breast cancer lesion requiring breast conserving surgery. Medisch Spectrum Twente Enschede: ≥100, ≥ 18 year old, with a nonpalpable histologically proven in situ or invasive breast cancer lesion requiring breast conserving surgery.
Main study parameters/endpoints: Percentage of radical excisions and the re-excision rate.
Doel van het onderzoek
RFID localization for nonpalpable breast lesions is a feasible, non-radioactive alternative for I125-seed localization with regard to the percentage of radical excisions (radical, focally irradical, more than focally irradical) and re-excision rate.
Onderzoeksopzet
Start RFID Localizer 1 Trial: september 2019
Expected completion of target inclusion: end 2020
Algemeen / deelnemers
Bianca Marina den Dekker
088 755 5555
b.m.dendekker-3@umcutrecht.nl
Wetenschappers
Bianca Marina den Dekker
088 755 5555
b.m.dendekker-3@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in the cohort study, a subject must meet all of the following inclusion criteria:
1. Female patient ≥ 18 years of age
2. Nonpalpable histologically proven in situ or invasive breast cancer that requires excision
3. Patient is scheduled for breast conserving surgery
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from participation in the cohort study:
1. Breast lesion is located deeper than 7 cm from the skin when lying supine
2. Multicentric breast cancer
3. Pregnancy or lactating
4. Subject is unable to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to her
Opzet
Deelname
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| Register | ID |
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