TABLE 2.
Name | Biomarker | Fluorophore | Registration no. | Indication | Participants | Patients (ovarian cancer) | Phase | Update | Status | Administration | Sensitivity | Specificity | Positive predictive value | Negative predictive value | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Type I | FITC | Folate receptor alpha (FRα) | Cyanine dye | NCT02000778 | Ovarian cancer | 10 | NA | Phase 1 | 2018 | Completed | NA | NA | NA | NA | NA |
NCT01511055 | Ovarian cancer | NA | 27 | Phase 2 | 2020 | Terminated |
0.1 mg/kg IV 2–3 h prior to surgery |
NA | NA | NA | NA | ||||
OTL38 | Folate receptor alpha (FRα) | Cyanine dye | 2013‐004774‐10/2014‐002352‐12 | Ovarian cancer | 30 | 12 | Phase 1/2 | 2016 | Completed |
0.0125 mg/kg 2–6 h prior surgery |
NA | NA | NA | NA | |
NCT02317705 | Ovarian cancer | NA | 44 | Phase 2 | 2019 | Completed |
0.025 mg/kg 2–3 h prior to surgery |
85% | 87% | 88% | 9% | ||||
NCT03180307 | Ovarian cancer | NA | 109 | Phase 3 | 2022 | Completed |
0.025 mg/kg 1 h prior to surgery |
86% | 31% | 64% | 43% | ||||
Type II | ONM‐100 | pH | ICG | NTR number 7085 | Head and neck squamous cell carcinoma, breast cancer, oesophageal cancer and colorectal cancer | 135 | 0 | Phase 1 | 2020 | Completed |
0.1–1.2 mg/kg 24 ± 8 h prior to surgery |
100% | 75% | 64% | 100% |
NCT03735680 | Head and neck squamous cell carcinoma, breast cancer, oesophageal cancer, colorectal cancer, ovarian cancer | 30 | NA | Phase 2 | 2022 | Completed | NA | NA | NA | NA | NA | ||||
NCT04950166 | Peritoneal carcinomatosis from the metastasis of a primary cancer of the peritoneum (e.g. appendiceal, ovarian, uterine, colorectal and gastric cancers) | 40 | NA | Phase 2 | 2022 | Recruiting |
1 mg/kg 24–72 h prior to surgery |
NA | NA | NA | NA |
Abbreviations: EOC, epithelial ovarian cancer; NA, not applicable.