Original Title: Identificación intraoperatoria fluorescente de células cancerosas

Authors' objectives: To inform the Spanish National Health System, through gathering the evidence available on the LumiSystemTM imaging system for the identification of cancer cells in clinical practice.

Authors' results and conclusions: The studies included were carried out between 2015 and 2022, all in the USA. Overall, 78% of studies focused on breast cancer, 22% on sarcoma and 10% on pancreas, colorectal or oesophageal cancer. Eight studies (90%) evaluated the efficacy of the LumiSystemTM imaging system, by measuring the mean tumour-to-normal signal ratios, sensitivity and specificity. On the other hand, six studies (67%) analysed the safety of LumiSystemTM. Safety was assessed by recording adverse events after the injection of LUM015. The studies retrieved indicate that this system seems safe, the adverse effects described including urine staining and one case report of a serious adverse event which did not state whether it was due to the patient’s condition or the use of the fluorescent dye. The other studies have not reported any notable adverse events and indicate good tolerability and safety of this technology using various different doses of fluorescent dye tested. The available evidence shows that the LumiSystemTM imaging system may be an effective and safe tool in cancer surgery for evaluating surgical margins intraoperatively. The studies identified are of low quality, and therefore, better-designed studies with larger sample sizes are needed to provide more robust data. There is also a need for information and studies that provide data on which organisational, economic, ethical and value issues, as well as patient-related factors, should be taken into account to inform and support decision-making concerning the widespread implementation of this novel technology in clinical practice.

Authors' methods: A scoping review of the scientific literature was conducted to identify studies assessing the LumiSystem™ imaging system. In July 2023, specific search strategies were employed, tailored to each database, using keywords related to the technology under study: lum imaging system or lumicell or lum015.

Project Status: Completed

Year Published: 2025

URL for published report: https://www.euskadi.eus/contenidos/informacion/osteba_publicacion/eu_def/adjuntos/E-25-07-Identificacion_intraoperatoria_fluorescente_.pdf

English language abstract: An English language summary is available

Publication Type: Rapid Review

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government</p>