Skip to main content

Table 2 Assessment schedule for patients who received diagnostic and therapeutic injection

From: Phase I study of [131I] ICF01012, a targeted radionuclide therapy, in metastatic melanoma: MELRIV-1 protocol

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

          
  1. aa single therapeutic injection (TI) of 800 MBq/m2, or 1600 MBq/m2, or 2700 MBq/m2 or 4000 MBq/m2 of [131I]ICF01012