Table 3.
Clinical trials of ICG guided tumor and sentinel lymph node imaging in head and neck cancer.
| ClinicalTrials.Gov Identifier | Start | No. of Patients | Target | Timing | Dose | Primary and Secondary Outcome | Country |
|---|---|---|---|---|---|---|---|
| NCT02027831 | 2013 | 10 | All patients requiring neck dissection with or without resection of the primary head and neck cancer | Intravenous injection before the surgery | 0.25 mg/kg | distribution of ICG in the normal and pathological lymph nodes | Belgium |
| NCT02640170 | 2015 | 500 | Resectable solid tumors (lung, breast, kidney, parathyroid, prostate, stomach, head and neck etc.) | NA | NA | monitor the rate of recurrence in patients who undergo cancer surgery. (prospective design) |
USA |
| NCT02920216 | 2016 | 10 | Salvage surgery for recurrence of head and neck cancer in irradiated area | Intravenous injection before the surgery | 0.25 mg/kg | Sensitivity of ICG in irradiated area and surgical margins | France |
| NCT02997553 | 2017 | 744 | ICG guided SLN biopsy compared with the 99mTc guided SLN biopsy in patients with cancers and subjected to surgery. (breast, head and neck, melanoma, cervix, rectum etc.) | Intravenous injection | 2.5 mg/mL | Non-inferiority of ICG guided SLN biopsy | France |
| NCT03745690 | 2018 | 20 | Head and neck cancer | Intravenous injection the day before surgery | NA | safety profile of high-dose ICG, the efficacy of high-dose ICG to identify cancer compared to surrounding normal tissue | USA |