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iROLL: does 3-D radioguided occult lesion localization improve surgical management in early-stage breast cancer?

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European Journal of Nuclear Medicine and Molecular Imaging Aims and scope Submit manuscript

Abstract

Purpose

To prospectively evaluate the feasibility of 3-D radioguided occult lesion localization (iROLL) and to compare iROLL with wire-guided localization (WGL) in patients with early-stage breast cancer undergoing breast-conserving surgery and sentinel lymph node biopsy (SLNB).

Methods

WGL (standard procedure) and iROLL in combination with SLNB were performed in 31 women (mean age 65.1 ± 11.2 years) with early-stage breast cancer and clinically negative axillae. Patient comfort in respect of both methods was assessed using a ten point scale. SLNB and iROLL were guided by freehand SPECT (fhSPECT). The results of the novel 3-D image-based method were compared with those of WGL, ultrasound-based lesion localization, and histopathology.

Results

iROLL successfully detected the malignant primary and at least one sentinel lymph node in 97 % of patients. In a single patient (3 %), only iROLL, and not WGL, enabled lesion localization. The variability between fhSPECT and ultrasound-based depth localization of breast lesions was low (1.2 ± 1.4 mm). Clear margins were achieved in 81 % of the patients; however, precise prediction of clear histopathological surgical margins was not feasible using iROLL. Patients rated iROLL as less painful than WGL with a pain score 0.8 ± 1.2 points (p < 0.01) lower than the score for iROLL.

Conclusion

iROLL is a well-tolerated and feasible technique for localizing early-stage breast cancer in the course of breast-conserving surgery, and is a suitable replacement for WGL. As a single image-based procedure for localization of breast lesions and sentinel nodes, iROLL may improve the entire surgical procedure. However, no advantages of the image-guided procedure were found with regard to prediction of complete tumour resection.

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Conflicts of interest

A.K.B. and K.H. are cofounders and shareholders of SurgicEye GmbH, Munich, Germany. C.B. had received a research grant from IZKF (Interdisziplinäres Zentrum für Klinische Forschung) Würzburg. All other authors declare that they have no conflicts of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the principles of the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.

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Correspondence to Christina Bluemel.

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Bluemel, C., Cramer, A., Grossmann, C. et al. iROLL: does 3-D radioguided occult lesion localization improve surgical management in early-stage breast cancer?. Eur J Nucl Med Mol Imaging 42, 1692–1699 (2015). https://doi.org/10.1007/s00259-015-3121-7

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  • DOI: https://doi.org/10.1007/s00259-015-3121-7

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