title: The superparamagnetic iron oxide tracer: a valid alternative in sentinel node biopsy for breast cancer treatment.
abstract: The European Union has determined that from 2016 breast cancer patients should be treated in Specialist Breast Units that achieve the minimum standards for the mandatory quality indicators as defined by Eusoma. The existing standard for axillary lymph node staging in breast cancer is sentinel node biopsy (SNB), performed using Technetium-sulphur colloid (99mTc) alone or with blue dye. The major limits of radioisotope consist in the problems linked to radioactivity, in the shortage of tracer and nuclear medicine units. Among existing alternative tracers, SentiMag®, which uses superparamagnetic iron oxide particles, can represent a valid option for SNB. We conducted a paired, prospective, multicentre study to evaluate the non-inferiority of SentiMag®vs.99mTc. The primary end point was the detection rate (DR) per patient. The study sample consists of 193 women affected by breast carcinoma with negative axillary assessment. The concordance rate per patients between99mTc and SentiMag®was 97.9%. The DR per patient was 99.0% for99mTc and 97.9% for SentiMag®. SentiMag®appears to be non-inferior to the radiotracer and safe. While99mTc remains the standard, SentiMag®DR appears adequate after a minimum learning curve. In health care settings where nuclear medicine units are not available, SentiMag/Sienna+®allows effective treatment of breast cancer patients.
authors.affiliation: Breast Cancer Center, University Hospital of Pisa, Via Roma, Pisa, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Ghilli
authors.affiliation: Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Carretta
authors.affiliation: Department of General and Breast Surgery, Regina Elena National Tumour Institute, Roma, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Di Filippo
authors.affiliation: Breast Surgery, Sanremo Civic Hospital, Sanremo, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Battaglia
authors.affiliation: Breast Cancer Center, University Hospital of Pisa, Via Roma, Pisa, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Fustaino
authors.affiliation: Department of General and Breast Surgery, Regina Elena National Tumour Institute, Roma, Italy.
authors.forename: I
authors.initials: I
authors.lastname: Galanou
authors.affiliation: Department of General and Breast Surgery, Regina Elena National Tumour Institute, Roma, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Di Filippo
authors.affiliation: Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Rucci
authors.affiliation: Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.
authors.forename: M P
authors.initials: MP
authors.lastname: Fantini
authors.affiliation: Breast Cancer Center, University Hospital of Pisa, Via Roma, Pisa, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Roncella
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000071960:Breast Carcinoma In Situ / Q000175:diagnosis*; D001943:Breast Neoplasms / Q000175:diagnosis*; D018270:Carcinoma, Ductal, Breast / Q000175:diagnosis*; D003287:Contrast Media; D055088:Early Detection of Cancer / Q000379:methods; D005260:Female; D005290:Ferric Compounds; D006801:Humans; D008207:Lymphatic Metastasis; D058185:Magnetite Nanoparticles; D008875:Middle Aged; D011446:Prospective Studies; D021701:Sentinel Lymph Node Biopsy
chemical_list: D003287:Contrast Media; D005290:Ferric Compounds; D058185:Magnetite Nanoparticles; C000499:ferric oxide
keywords: breast cancer; breast unit; radioisotope; sentinel lymph node biopsy; superparamagnetic iron oxide particles