Table 1.
The schedule of study assessments is set out as follows
| Visit name | Screening | IMP administration | Imaging | Follow-up |
| Time point | Day −28 to −1 | Day 0 | Day 5±2 | Day 14 (Or before starting chemotherapy or undergoing surgery) |
| Informed consent | X | |||
| Eligibility criteria | X | |||
| 18F-FDG-PET/CT | X | |||
| Physical exam | X | |||
| ECOG status | X | |||
| Vital signs | X | X Preinjection and postinjection |
X | |
| 12-lead ECG | X | X Postinjection |
||
| Haematology Biochemistry |
X | |||
| Liver function tests | X | |||
| Serum β-HCG | X | |||
| Urine analysis | X | |||
| Urine pregnancy test | X | |||
| PET/CT | X | |||
| Adverse events | X | X | X | |
| Concomitant medications | X | X | X | X |
ECOG, Eastern Cooperative Oncology Group; 18F-FDG-PET/CT, 18F-fluorodeoxyglucose positron emitting tomography/CT; β-HCG, beta-human chorionic gonadotropin.