Table 3.
Human studies of ICG-FI for breast cancer tumor detection and intraoperative margin evaluation
| Author (year) | No. of patients | Type of BC tumor | Tumor grade | FI type | Imaging system | ICG dose | Timing of IV ICG injection | Accuracy of ICG-FI | Mean TBR (ex vivo) | TBR (calculation program) | Size of detected lesion |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Keating et al.a [10] (2016) | 12 |
IDC = 9 ILC = 3 |
Not specified | In vivo/ex vivo |
FloCam (BioVision) Artemis Fluorescence Imaging system (Quest Medical Imaging) Iridium (Visionsense) |
5 mg/kg | 24 h before surgery (20.8–27 h) |
Se = 100% FPRa = 50% |
3.7 | ImageJ software (NIH, Bethesda) | 7–26 mm |
| Veys et al. [31] (2018) | 8b |
IDC = 8 ILC = 1 |
Gr2 = 2 Gr3 = 6 |
Ex vivo | Fluobeam 800 (Fluoptic) | 0.25 mg/kg | 47–135 min before surgery |
Se = 94.2% Sp = 31.7% NPV = 92.7% FPR = 68% |
3.3 (SD 1.7) | IC-Calc 2.0 | NA |
| Pop et al.a [4] (2021) | 35 |
IDC = 32 ILC = 3 |
Gr1 = 20 Gr2 = 7 Gr3 = 8 |
In vivo/ex vivo | Fluobeam 800 (Fluoptic) | 0.25 mg/kg | 20–83 min before surgery |
Se = 88.6% (31/35) Sea = 100% Spa = 60% NPVa = 100 FPRa = 40% |
2.4 (1.5) | IC-Calc 2.0 | 4–40 mm |
| Bourgeois et al. [15] (2021) | 5c | NA | Not specified | Ex vivo | PDE (Hamamatsu Photonics) | 0.25 mg/kg | 24 h before surgery | Se = 40% (2 of 5 patients) | 2.7 | IC-Calc 2.0 | NA (2 mm the small BC tumor foci) |
| Leiloglou et al. [32] (2021) | 10 (5) |
IDC = 8 ILC = 1 IMC = 1 |
Not specified | In vivo/ex vivo | Locally developed system | 12 mg/patient | Not specified (< 5 min, vascular phase) | AUC = 0.58–0.88 | NA | Matlab software (Mathworks, Inc., Massachusetts, USA) | NA |
| Kedrzycki et al. [33] (2021) | 32 (16 EPR vs 16AP) |
IDC = 17 vs. 12 ILC = 1 vs. 3 IMC = 1 vs. 0 IMPC = 0 vs. 1 DCIS = 1 vs. 3 |
Not specified | Ex vivo | Locally developed system | 0.25 mg/kg | 25 and 5 min |
Se = 72% vs. 85% Sp = 93% vs. 98% NPV = NA FPR = NA |
2.1 (0.9) vs. 3.2 (1.7) |
Matlab software (Mathworks, Inc., Massachusetts, USA) |
1.7–30 mm vs. 0–34 mm |
| Hwang et al.a [16] (2022) | 43 |
IDC = 36 IMPC = 3 IMC = 2 DCIS = 2 |
Not specified | In vivo/ex vivo | Real-IGS, (Nuoyuan Medical Equipment) | 0.5 mg/kg | 2 h before surgery |
Se = 100% (43/43) Sea = 93.3% Spa = 96% |
2.14 (0.6) | ImageJ software (NIH, Bethesda) |
≤2 cm (67.4%) 2–4 cm (32.6%) |
AUC area under the curve, BC breast cancer, DCIS ductal carcinoma in situ, FPR false positive rate, IDC invasive ductal carcinoma, ILC invasive lobular carcinoma, IMC invasive mucinous carcinoma, IMPC invasive micropapillary carcinoma, NA not applicable, NPV negative predictive value, SD standard deviation, Se sensitivity, Sp specificity
aIntraoperative margin evaluations
bTreated by neoadjuvant chemotherapy
cOnly the results of the groups of patients allocated in the first study protocols