Table 1 Assessment schedule for patients who received diagnostic injection and were not eligible to therapeutic part
TIMEPOINT | Screenig / baseline | Selection part | Follow-up period | ||||
|---|---|---|---|---|---|---|---|
Week | W0 | W1 | W2 | W3 | |||
Day | −30 to −1 | D0 | D1 | D4 | D7 | D14 ± 4 | D35 ± 4 |
Informed consent | ✓ | ||||||
Medical history and demographic | ✓ | ||||||
Prior / concomitant medication | ✓ | Collecting during all the study | |||||
Adverse event evaluation | ✓ | Collecting during all the study | |||||
Physical exam | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Vital signs | ✓ | ✓before, 5 min, 30 min, 1 h, 3 h after | ✓ | ✓ | ✓ | ✓ | ✓ |
Performance status OMS | ✓ | ✓ | ✓ | ✓ | ✓ | ||
ECG | ✓ | ✓ | |||||
LVEF | ✓ | ||||||
Dermatologist consultation | ✓ | ✓ | |||||
Ophthalmologist consultation | ✓ | ✓ | |||||
Neurologist consultation | ✓ | ✓ | |||||
Imaging acquisition for dosimetry | ✓30 min, 1 h, 3 h after | ✓ | ✓ | ✓ | |||
Disease evaluation | ✓ | ||||||
Pregnancy test | ✓ | ||||||
Hematology and coagulation | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Blood chemistry | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Thyroid function | ✓ | ✓ | |||||
Urinalysis | ✓ | ✓ | ✓ | ||||
Pharmacokinetic sample | ✓Before, 5, 10, 15, 30 min, 1 h, 3 h after | ✓ | ✓ | ✓ | |||
[131I]ICF01012 | ✓ 185 MBq | ||||||