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

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.

SUBMITTER: Verver D

PROVIDER: S-EPMC6132503 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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

Verver Daniëlle D Oude Ophuis Charlotte M C CMC Koppert Lisa B LB de Monyé Cécile C van Deurzen Carolien H M CHM Koljenović Senada S Bruining Annemarie A van der Hiel Bernies B Ter Meulen Sylvia S van Akkooi Alexander C J ACJ Verhoef Cornelis C Grünhagen Dirk J DJ

European journal of nuclear medicine and molecular imaging 20180426 11

<h4>Purpose</h4>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 detectin ...[more]

PMID: 29700573

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Project description:ObjectiveTo evaluate the feasibility and diagnostic performance of ultrasound (US)-guided fine-needle aspiration cytology and core-needle biopsy (US-FNAC/CNB) for the diagnosis of laryngo-hypopharyngeal masses.Materials and methodsThis was a single-center prospective case series. From January 2018 to June 2019, we initially enrolled 40 patients with highly suspicious laryngo-hypopharyngeal masses on laryngoscopic examinations. Of these, 28 patients with the mass involving or abutting the pre-epiglottic, paraglottic, pyriform sinus, and/or subglottic regions were finally included. These patients underwent US examinations with/without subsequent US-FNAC/CNB under local anesthesia for evaluation of the laryngo-hypopharyngeal mass.ResultsOf the 28 patients who underwent US examinations, a laryngo-hypopharyngeal mass was identified in 26 patients (92.9%). US-FNAC/CNB was performed successfully in 25 of these patients (96.2%), while the procedure failed to target the mass in 1 patient (3.8%). The performance of US caused minor subclinical hematoma in 2 patients (7.7%), but no major complications occurred. US-FNAC/CNB yielded conclusive results in 24 (96.0%) out of the 25 patients with a successful procedure, including 23 patients with squamous cell carcinoma (SCC) and 1 patient with a benign mass. In one patient with atypical cells in US-FNAC, additional direct laryngoscopic biopsy (DLB) was required to confirm SCC. Among the 26 patients who received US-FNAC/CNB, the time from first visit to pathological diagnosis was 7.8 days. For 24 patients finally diagnosed with SCC, the time from first visit to the initiation of treatment was 25.2 days. The mean costs associated with US-FNAC/CNB was $272 under the Korean National Health Insurance Service System.ConclusionUS-FNAC/CNB for a laryngo-hypopharyngeal mass is technically feasible in selected patients, providing good diagnostic performance. This technique could be used as a first-line diagnostic modality by adopting appropriate indications to avoid general anesthesia and DLB-related complications.

Project description:ObjectiveThe main aim of this study was to ascertain the effectiveness of ultrasound-guided fine needle aspiration cytology (US-FNAC) in the diagnosis of para-aortic lymph node (PALN) metastasis in uterine cervical cancer and to establish its potential impact on clinical therapeutic decision making.MethodsWe retrospectively reviewed clinical data from 92 patients diagnosed with cervical cancer with PALN enlargement between 2010 and 2018. Cytological results obtained with US-FNAC were classified by the same experienced cellular pathologists. Diagnostic indicators were determined on the basis of biopsy, imaging and clinical follow-up results. Univariate and multivariate analyses were used to assess the differences of influencing factors. The effect of US-FNAC on clinical decision making was evaluated.ResultsCytological results of US-FNAC were categorized as malignancy (n = 62; 67.4%), suspicious malignancy (n = 11; 12.0%), undetermined (n = 5; 5.4%), benign (n = 10; 10.9%), and inadequate (n = 4; 4.3%). Satisfactory biopsy samples were obtained from 95.7% of PALNs sampled (88/92). The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of FNAC in distinguishing benign from malignant cases were 90.1% (95% CI: 0.809-0.953), 100% (95% CI: 0.561-1), 100% (95% CI: 0.938-1), 46.7% (95% CI: 0.223-0.726) and 90.9% (95% CI: 0.848-0.970), respectively. Univariate analysis indicated significant differences in experience of puncture physicians (radiologists) between the correct and wrong diagnosis groups (P < 0.05), which was further confirmed as an independent predictor of diagnostic accuracy in multivariate analysis (p = 0.031, OR = 0.077, 95% CI: 0.354-0.919). All patients tolerated the US-FNAC procedure well and only nine presented slight abdominal discomfort. The therapeutic strategies for 74 patients (80.4%) were influenced by US-FNAC findings.ConclusionsUS-FNAC was a relatively safe and effective technique for examination of enlarged para-aortic lymph nodes and may therefore serve as a routine diagnostic tool to guide clinical decision making for management of cervical cancer.

Dataset Information

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

Publications

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

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