Figure 1

Trial schema. A total of 400 subjects (240 invasive squamous cell carcinoma and 160 severe dysplasia or carcinoma in situ) will be randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up.