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Clinical Trial
. 2018 Oct;45(11):1926-1933.
doi: 10.1007/s00259-018-4014-3. Epub 2018 Apr 26.

Gamma probe and ultrasound-guided fine needle aspiration cytology of the sentinel node (GULF) trial

Daniëlle Verver  1 , Charlotte M C Oude Ophuis  2 , Lisa B Koppert  2 , Cécile de Monyé  3 , Carolien H M van Deurzen  4 , Senada Koljenović  4 , Annemarie Bruining  5 , Bernies van der Hiel  6 , Sylvia Ter Meulen  7 , Alexander C J van Akkooi  7 , Cornelis Verhoef  2 , Dirk J Grünhagen  2
Affiliations
Clinical Trial

Gamma probe and ultrasound-guided fine needle aspiration cytology of the sentinel node (GULF) trial

Daniëlle Verver et al. Eur J Nucl Med Mol Imaging. 2018 Oct.

Abstract

Purpose: Sentinel lymph node biopsy (SLNB) was introduced as a minimally invasive technique for nodal staging. Since associated morbidity is not negligible, it is highly relevant to pursue a more minimally invasive alternative. The purpose of this study was to prospectively evaluate the sensitivity of fine needle aspiration cytology (FNAC) with combined gamma probe and ultrasound (US) guidance in comparison with the gold standard histology of the sentinel node (SN) after SLNB for detecting metastasis.

Methods: The study was designed as a prospective, multicentre, open-label, single-arm trial enrolling patients with newly diagnosed cutaneous melanoma or breast cancer between May 2015 and August 2017. Sample radioactivity was measured using a Mini 900 scintillation monitor. After FNAC, all patients underwent SLNB. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were estimated.

Results: Accrual was terminated early following an unplanned interim analysis indicating that a FNAC sensitivity of at least 80% could not be achieved. In total 58 patients of the originally planned 116 patients underwent FNAC with gamma probe and US guidance. There were no true-positive FNAC results, 14 false-negative results and one false-positive result, and thus the sensitivity, specificity, PPV and NPV of FNAC were 0%, 98%, 0% and 75%, respectively. At least 75% of the FNAC samples had a radioactivity signal higher than the background signal.

Conclusion: FNAC with gamma probe and US guidance is not able to correctly detect metastases in the SN and is therefore not able to replace SLNB. Gamma probe-guided US is a highly accurate method for correctly identifying the SN, which offers possibilities for future research.

Keywords: Breast cancer; Fine needle aspiration cytology; Gamma probe; Melanoma; Sentinel lymph node biopsy; Ultrasound.

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Conflict of interest statement

Conflicts of interest

None.

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.

This article does not describe any studies with animals performed by any of the authors.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Figures

Fig. 1
Fig. 1
Identification of the presumed sentinel node in the axilla (A) using the ultrasound probe (B), gamma probe (C) and the skin mark (D)
Fig. 2
Fig. 2
Selection of patients who underwent FNAC with gamma probe and US guidance
See this image and copyright information in PMC

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