A randomized controlled trial to compare near-infrared fluorescence imaging with standard-of-care sentinel lymph node mapping in vulvar cancer patients

A phase II, randomized controlled trial to determine the efficacy of identification of SLN(s) in vulvar cancer patients by standard-of-care compared to near-infrared (NIR) fluorescence imaging. Standard-of-care SLN mapping consists of preoperative peritumoral injections of 99mTc-nanocolloid and during surgery a peritumoral injection of patent blue. Patients who undergo NIR fluorescence imaging will receive a preoperative injection of indocyanine green (ICG) premixed with 99mTc-nanocolloid (ICG:99mTc). During the surgical procedure NIR fluorescence imaging will be performed. Patent blue will only be injected when the SLN cannot be identified by NIR fluorescence imaging, to give the patient standard-of-care.

Peritumoral injections of combined ICG:99mTc may be superior to standard-of-care and may facilitate the SLN procedure by real time near-infrared intra-operative guidance.

End of the trial.

Patients will be randomized by computer into 2 groups. Standard-of-care SLN mapping implies 3-4 peritumoral intracutaneous injections of approximately 0.5ml 30-100MBq 99mTc-nanocolloid 3-24 hours before surgery. After general or locoregional anesthesia, prior to the first groin incision, 1-2 mL of patent blue V will be injected peritumorally. The second group of patients will receive 3-4 peritumoral intracutaneous injections of ICG:99mTc (also 30-100MBq 99mTc-nanocolloid in total) 3-24 hours before surgery, given by the Nuclear Department or by the Gynaecologist. Intraoperatively, it will be attempted to visualize SLNs. In case the SLN cannot be found in the second group of patients, patent blue will be administered as well. Postoperatively, short and long term morbidity will be registered in all patients, as defined by the endpoints.