title: Sentinel lymph node localization with contrast-enhanced ultrasound and an I-125 seed: an ideal prospective development study.
abstract: BACKGROUND
  Our aim was to evaluate the development of microbubble-enhanced sentinel lymph node (SLN) localization with placement of an I-125 seed in breast cancer patients as a potential alternative for SLN localization with nanocolloid. The study is conducted and reported following the IDEAL recommendations for evaluation of a new technique at Stage 2a (Prospective Development Study).
  
  
  METHODS
  Fourteen consecutive patients with 15 lesions underwent microbubble-enhanced SLN localization with placement of an I-125 seed after the standard SLN localization (nanocolloid). We placed an I-125 seed within or near the SLN following its identification using intradermally injected microbubbles. The SLN was excised guided by nanocolloid and the SLN containing the I-125 seed was searched for. All technical modifications are described and standardized outcomes measured.
  
  
  RESULTS
  Twelve (80%) microbubble procedures with I-125 seed placements were technically successful. In three cases no microbubble-enhancing lymph node could be detected. Intraoperatively, we found nine I-125 seeds within 0.5 cm of the nanocolloid confirmed SLN. One I-125 seed was found next to a non-SLN and two I-125 seeds were not near any lymph node. Overall, the procedure was successful in 60% (9 out of 15) of the cases.
  
  
  CONCLUSIONS
  Given the low success rate, we conclude that microbubble-enhanced SLN is not a viable alternative to the standard SLN procedure. Modifications to this technique did not improve its performance. Planned study (NTR3690 http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3690) was stopped early due to this conclusion and results reported in order to provide a full and transparent record of the evolution of technique.
authors.affiliation: Department of Radiology, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands. Electronic address: m.barentsz@umcutrecht.nl.
authors.forename: M W
authors.initials: MW
authors.lastname: Barentsz
authors.affiliation: Imaging Division, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands.
authors.forename: H M
authors.initials: HM
authors.lastname: Verkooijen
authors.affiliation: Department of Radiology, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands.
authors.forename: R M
authors.initials: RM
authors.lastname: Pijnappel
authors.affiliation: Department of Radiology, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands.
authors.forename: M A
authors.initials: MA
authors.lastname: Fernandez
authors.affiliation: Department of Pathology, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands.
authors.forename: P J
authors.initials: PJ
authors.lastname: van Diest
authors.affiliation: Department of Surgery, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands.
authors.forename: C C
authors.initials: CC
authors.lastname: van der Pol
authors.affiliation: Department of Surgery, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands.
authors.forename: A J
authors.initials: AJ
authors.lastname: Witkamp
authors.affiliation: Department of Nuclear Medicine, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands.
authors.forename: M G G
authors.initials: MG
authors.lastname: Hobbelink
authors.affiliation: Department of Radiology, University of Hacettepe, Faculty of Medicine, Sıhhiye, 06100 Ankara, Turkey.
authors.forename: A R
authors.initials: AR
authors.lastname: Sever
authors.affiliation: Department of Radiology, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands.
authors.forename: M A A J
authors.initials: MA
authors.lastname: van den Bosch
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology* / Q000601:surgery; D018270:Carcinoma, Ductal, Breast / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D003287:Contrast Media; D005260:Female; D006801:Humans; D007089:Image Enhancement; D007457:Iodine Radioisotopes; D008207:Lymphatic Metastasis; D045423:Microbubbles; D008875:Middle Aged; D011446:Prospective Studies; D019275:Radiopharmaceuticals; D021701:Sentinel Lymph Node Biopsy / Q000379:methods*; D013668:Technetium Tc 99m Aggregated Albumin; D016217:Ultrasonography, Mammary
chemical_list: D003287:Contrast Media; D007457:Iodine Radioisotopes; D019275:Radiopharmaceuticals; D013668:Technetium Tc 99m Aggregated Albumin; C083602:technetium Tc 99m nanocolloid
keywords: Breast cancer; Contrast-enhanced ultrasound; IDEAL framework; Radioactive seed; Sentinel lymph node