TIMEPOINT | Screenig / baseline | Selection part | Therapeutic part | Follow-up period | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week | W0 | W1 | W2 | W3 | W5 | W7 | W10 | W13 | ||||||||
Day | −30 to −1 | D0 | D1 | D4 | D7 | D11 ± 4 | D12 ± 4 | D13 ± 4 | D15 ± 4 | D16 ± 4 | D18 ± 4 | D25 ± 4 | D39 ± 4 | D53 ± 4 | D74 ± 4 | D96 ± 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, 30 min, 1 h, 3 h after injection | ✓ | ✓ | ✓ | ✓ before, 5, 30 min, 1 h, 3 h after injection | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Performance status OMS | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
ECG | ✓ | ✓ | ✓ | |||||||||||||
LVEF | ✓ | ✓ | ||||||||||||||
Dermatologist consultation | ✓ | ✓ | ✓ | ✓ | ||||||||||||
Ophthalmologist consultation | ✓ | OCT | ✓OCT | ✓ | ||||||||||||
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 | ✓ TIa |