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Table 1 Study procedures

From: Dose finding study for unilobar radioembolization using holmium-166 microspheres to improve resectability in patients with HCC: the RALLY protocol

Procedures

Screen

Scout

Treatment

SPECT/CT

Follow-upa

S

Post-S visitb

Informed consent

E

      

In-/exclusion

E

E

     

Demographic data

X

      

Physical exam, vital signs and clinical performance status (ECOG)

X

E

X

 

X

X

X

EORTC QLQ C30,

HCC 18, BPI-SF

E

E

E

 

E

E

E

MRI / CT liver

X

   

Xc

Xc

Xc

CT thorax

X

      

HBS

X

   

X

  

Angiography

 

E

Ed

    

Scout dose

 

E

     

Therapeutic dose

  

E

    

SPECT/CT + contrast CT

 

E

 

Ee

   

Laboratory examination

X

E

X

 

X

X

X

Monitoring of (S)AE’s + 

concomitant med

 

E

X

 

X

X

X

Pregnancy test

 

X

     
  1. E = extra activity in study context, X = standard care, W = week, M = month, S = Surgery
  2. aExact interval is at 1.5, 3, 4.5, 6 and 9 months. However, post-radioembolization follow up will be discontinued as soon as patients are eligible to undergo surgical resection. bThree months following surgery. cMRI is standard. CT is performed if MRI is contraindicated. dVenogram when standard therapy (PVE) is performed. eThree to four days after the therapeutic treatment, at separate visit in outpatient clinic