Detection of Prostate Cancer Metastases During Pelvic Lymph Node Dissection with the PSMA-Targeted Fluorescent Agent OTL78: A Phase II Study.

IF 2.5 4区医学 Q2 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING

Molecular Imaging and Biology Pub Date : 2025-12-01 Epub Date: 2025-10-09 DOI:10.1007/s11307-025-02052-x

Judith A Stibbe, Daan F G Linders, Robin A Faber, Rob F M Bevers, Erik J van Gennep, Stijn A S L P Crobach, Shadhvi S Bhairosingh, Timothy G Biro, Prof Jacobus Burggraaf, Prof Alexander L Vahrmeijer

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引用次数: 0

Abstract

Purpose: This study aimed to assess the feasibility of intraoperative fluorescence imaging using the PSMA-targeted fluorescent tracer OTL78 for detecting lymph node metastases during pelvic lymph node dissection (PLND) in patients undergoing staging or salvage surgery for prostate cancer.

Procedures: In a prospective pilot study, six patients scheduled for robot-assisted PLND received a single intravenous infusion of OTL78 at a dose of either 0.06 mg/kg or 0.03 mg/kg, administered 1-2 h prior to surgery. Intraoperatively, lymph node clusters were evaluated using fluorescence imaging. Post-surgical histopathological analysis and immunohistochemistry were performed to confirm tumor presence and PSMA overexpression in fluorescent nodes. The primary outcome was the feasibility of fluorescence imaging in detecting metastatic lymph nodes during PLND.

Results: Fluorescence imaging demonstrated a sensitivity of 66.7% and specificity of 91.7% for identifying metastatic lymph nodes. The positive predictive value was 66.7%, and the negative predictive value was 91.7%. Metastasized lymph nodes (MLN) exhibited significantly higher median fluorescence intensity (MFI) than benign lymph nodes (BLN): 0.51 [IQR 0.11-0.74] vs. 0.06 [IQR 0.03-0.12], p = 0.024. Immunohistochemistry confirmed PSMA overexpression in fluorescent malignant regions. No adverse reactions to the tracer were reported.

Conclusions: Intraoperative fluorescence imaging with the tracer OTL78 is a feasible technique for identifying metastatic lymph nodes during PLND. Fluorescence guidance may assist in detecting small metastatic deposits within nodal clusters that are otherwise difficult to localize. Larger studies are needed to validate these findings and optimize the imaging protocol for broader clinical use.

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psma靶向荧光剂OTL78在盆腔淋巴结清扫中检测前列腺癌转移：一项II期研究

目的：本研究旨在评估psma靶向荧光示踪剂OTL78术中荧光成像检测前列腺癌分期或补救性手术患者盆腔淋巴结清扫（PLND）期间淋巴结转移的可行性。程序：在一项前瞻性先导研究中，6名计划接受机器人辅助PLND的患者在手术前1-2小时接受单次静脉输注OTL78，剂量为0.06 mg/kg或0.03 mg/kg。术中使用荧光显像评估淋巴结簇。术后组织病理学分析和免疫组织化学证实肿瘤存在和荧光淋巴结中PSMA过表达。主要结果是荧光成像在PLND期间检测转移淋巴结的可行性。结果：荧光显像鉴别转移性淋巴结的敏感性为66.7%，特异性为91.7%。阳性预测值为66.7%，阴性预测值为91.7%。转移性淋巴结（MLN）的中位荧光强度（MFI）明显高于良性淋巴结（BLN）： 0.51 [IQR 0.11-0.74]比0.06 [IQR 0.03-0.12], p = 0.024。免疫组化证实PSMA在荧光恶性区过表达。无不良反应的示踪剂报告。结论：术中荧光显像示踪剂OTL78是鉴别PLND转移淋巴结的一种可行技术。荧光引导可以帮助检测淋巴结簇内难以定位的小转移性沉积物。需要更大规模的研究来验证这些发现并优化成像方案以用于更广泛的临床应用。

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来源期刊

Molecular Imaging and Biology 医学-核医学

CiteScore

6.90

自引率

3.20%

发文量

审稿时长

3 months

期刊介绍： Molecular Imaging and Biology (MIB) invites original contributions (research articles, review articles, commentaries, etc.) on the utilization of molecular imaging (i.e., nuclear imaging, optical imaging, autoradiography and pathology, MRI, MPI, ultrasound imaging, radiomics/genomics etc.) to investigate questions related to biology and health. The objective of MIB is to provide a forum to the discovery of molecular mechanisms of disease through the use of imaging techniques. We aim to investigate the biological nature of disease in patients and establish new molecular imaging diagnostic and therapy procedures. Some areas that are covered are: Preclinical and clinical imaging of macromolecular targets (e.g., genes, receptors, enzymes) involved in significant biological processes. The design, characterization, and study of new molecular imaging probes and contrast agents for the functional interrogation of macromolecular targets. Development and evaluation of imaging systems including instrumentation, image reconstruction algorithms, image analysis, and display. Development of molecular assay approaches leading to quantification of the biological information obtained in molecular imaging. Study of in vivo animal models of disease for the development of new molecular diagnostics and therapeutics. Extension of in vitro and in vivo discoveries using disease models, into well designed clinical research investigations. Clinical molecular imaging involving clinical investigations, clinical trials and medical management or cost-effectiveness studies.