OBJECTIVES: This Hospital-Based Health Technology Assessment (HB-HTA) report provides a multidisciplinary and systematic assessment of using near-infrared fluorescence-guided surgery using indocyanine green (ICG) as a sentinel lymph node (SLN) mapping procedure for early-stage breast cancer and gynecologic cancer as a substitute for Technesium-99 (TC-99) and Blue Dye (BD) to inform hospital management’s decision on adopting this SLN mapping procedure.

METHODS: The report focuses on the hospital perspective in Italy and follows HB-HTA guidelines, covering the most relevant domains: technological aspects, effectiveness, safety, organizational and economic impact, social, legal, and ethical aspects. A systematic review of the existing literature was conducted according to the Cochrane Handbook for Systematic Reviews. Evidence was extracted according to predefined search strategies, inclusion and exclusion criteria, and was summarized in a reference framework based on the state of art HTA models. Results and methodologies were frequently discussed with the advisory board ensuring the reliability of the analysis. Qualitative, quantitative, or mixed assessments of the technology were performed according to the type of evidence investigated in the single domain.

RESULTS: The breast cancer analysis included 22 records published between 2002 and 2020. Of the 22 studies, 17 were prospective cohort studies, 5 were randomized control studies, and 4 were retrospective cohort studies. The gynecologic cancer analysis included 19 records published between 2014 and 2020 (20 studies extracted and analyzed). Of the 20 studies, 12 were retrospective cohort studies, and 8 were prospective cohort studies. There is no evidence in the literature about safety issues or significant reactions to ICG.

CONCLUSIONS: Studies support the use of ICG as a safe and effective alternative to using TC-99 and BD for SLN mapping for breast cancer and gynecologic cancer patients. ICG prehospitalization costs are also lower than TC-99 prehospitalization costs due to the avoidance of using the nuclear medicine department for the TC-99 injection.