Table 6. Summary current clinical trials using tumor-specific probes.
Tumor type | Probe | Clinical trial ID | Title | Institution | Investigator | n | Design | Dose | Timing | Fluorescence imaging system | Comparator | End points |
---|---|---|---|---|---|---|---|---|---|---|---|---|
CholangioCA | Bevacizumab-800CW | NCT03620292 | Fluorescence image guided surgery in CholangioCA (COUGAR) | University Medical Center Groningen | Van Dam et al. | 12 | Open label dose finding | 10, 25 or 50 mg of bevacizumab-800CW | 3 days before surgery | Not identified | Dose | Optimal dose of Bevacizumab-800CW; comparison of per-operative vs. ex-vivo analysis; detection of hilar cholangiocarcinoma intraoperatively; probe distribution; fluorescence signal in surrounding tissue |
Pancreatic cancer | Panitumumab-IRDye800 | NCT03384238 | Panitumumab-IRDye800 in patients with pancreatic cancer undergoing surgery | Stanford University | Rosenthal et al. | 24 | Open label single arm | Not identified | 2–5 days before surgery | Novadaq devices: SPY/LUNA, Pinpoint, IR9000 fluorescence imaging system, and/or SurgVision Explorer Air | Not applicable | Tumor-to-background ratio; adverse events; number of positive lymph nodes not detected by white light; number of positive resection margins not detected by white light |
Pancreatic cancer and metastatic colorectal cancer | SGM-101 | NCT02973672 | Phase I of SGM-101 in patients with cancer of the colon, rectum or pancreas | Center for human drug research, Netherlands, Leiden University Medical Center, Erasmus Medical Center | Burffraaf et al. | 60 | Open label single arm | Not identified | 4 days before surgery | Not identified | Not applicable | Rate of adverse events; tumor-to-background ratio; serum SGM-101 concentration |
Pancreatic cancer | Bevacizumab-800CW | NCT02743975 | Near-infrared image guided surgery in pancreatic adenocarcinoma (PENGUIN) | University Medical Center Groningen | Van Dam et al. | 26 | Open label dose finding | 4.5, 10, 25, or not 50 mg of bevacizumab-800CW | Not identified | Not identified | Dose | Mean fluorescence intensity in tumor vs. normal tissue; optimal dose; adverse events |
Pancreatic cancer | Cetuximab-800CW | NCT02736578 | Cetuximab-IRDye 800CW and intraoperative imaging in finding pancreatic cancer in patients undergoing surgery | Stanford University | Rosenthal et al. | 8 | Open label parallel arm | 50 vs. 100 mg loading dose of unlabeled cetuximab, 50 vs. 100 mg of labeled cetuximab | 2–5 days before surgery | Not identified | Dose | Assess dye uptake in tumor vs. non-cancerous tissue; measure fluorescence intensity; effect of dose on fluorescence intensity; sensitivity and specificity; detection in LNs; signal to noise ratios (ex vivo); signal to noise ratio (in vivo); toxicity |
CholangioCA, cholangiocarcinoma.