Gamma Probe and Ultrasound Guided Fine Needle Aspiration Cytology of the Sentinel Node (GULF) Trial - Overview of the Literature, Pilot and Study Protocol

Overview

Journal BMC Cancer

Publisher Biomed Central

Specialty Oncology

Date 2017 Apr 14

PMID 28403815

Citations 4

Authors

Charlotte M C Oude Ophuis

Lisa B Koppert

Cecile de Monye

Carolien H M van Deurzen

Senada Koljenovic

Alexander C J van Akkooi

Cornelis Verhoef

Dirk J Grunhagen

Affiliations

Soon will be listed here.

Abstract

Background: Sentinel node (SN) biopsy (SNB) detects clinically occult metastases of breast cancer and melanoma in 20-30%. Wound infections, seroma and lymph edema occur in up to 10%. Targeted ultrasound (US) of the SN, (with fine needle aspiration cytology (FNAC) if appropriate) has been investigated as a minimally invasive alternative, but reported sensitivity rates are too low to replace SNB. Our hypothesis is that the use of a handheld gamma probe concomitant with US may improve sensitivity. Our aim is to provide an overview of the current literature on preoperative nodal staging of clinical N0 melanoma patients, report on a pilot, and present a study protocol for a minimally invasive alternative to the SNB: Gamma probe and Ultrasound guided Fine needle aspiration cytology of the sentinel node (GULF trial).

Methods: The GULF trial is a multicenter open single arm observational trial. Newly diagnosed cT1b-4N0M0 cutaneous melanoma or cT1-3N0M0 breast cancer patients, aged >18 years, presenting for SNB are eligible. 120 patients will be included for preoperative targeted gamma probe guided US and FNAC of the SN. Afterwards all patients proceed to surgical SNB. Primary endpoint is the sensitivity of FNAC. Secondary endpoints include SN identification rate and the histopathological compatibility of Core Needle Biopsy and FNAC vs. SNB. Secondary endpoints were investigated in a pilot with 10 FNACs and marker placements, and 10 FNACs combined with Core Needle Biopsy.

Results: A pilot in 20 patients showed that SN identification rate was 90%, supporting the feasibility of this technique.

Discussion: There is broad experience with US (in combination with FNAC) prior to SNB, but sensitivity and specificity are too low to completely abandon SNB. Promising alternative techniques potentially will replace SNB in the future but more evidence is needed in the form of prospective studies. Accurate identification of the SN for US-FNAC has been proven feasible in our pilot. When adequate sensitivity can be reached, US-FNAC provides a minimally invasive alternative for the surgical SNB procedure.

Trial Registration: The GULF trial is registered in the Netherlands Trial Registry (NTR), ID: NRT5193 . May 1st 2015.

Citing Articles

Primary Melanoma: from History to Actual Debates.

Testori A, Blankenstein S, van Akkooi A Curr Oncol Rep. 2019; 21(12):112.

PMID: 31858280 DOI: 10.1007/s11912-019-0843-x.

Can integrated 18F-FDG PET/MR replace sentinel lymph node resection in malignant melanoma?.

Schaarschmidt B, Grueneisen J, Stebner V, Klode J, Stoffels I, Umutlu L Eur J Nucl Med Mol Imaging. 2018; 45(12):2093-2102.

PMID: 29876618 DOI: 10.1007/s00259-018-4061-9.

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

Verver D, Oude Ophuis C, Koppert L, de Monye C, van Deurzen C, Koljenovic S Eur J Nucl Med Mol Imaging. 2018; 45(11):1926-1933.

PMID: 29700573 PMC: 6132503. DOI: 10.1007/s00259-018-4014-3.

Erratum to: gamma probe and ultrasound guided fine needle aspiration cytology of the sentinel node (GULF) trial - overview of the literature, pilot and study protocol.

Oude Ophuis C, Koppert L, de Monye C, van Deurzen C, Koljenovic S, van Akkooi A BMC Cancer. 2017; 17(1):387.

PMID: 28558666 PMC: 5450197. DOI: 10.1186/s12885-017-3363-9.

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