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Table 1 Schedule for Screening and follow-up of the ALA-RDT in GBM study

From: ALA-RDT in GBM: protocol of the phase I/II dose escalation trial of radiodynamic therapy with 5-Aminolevulinic acid in patients with recurrent glioblastoma

 

Screening

for cohorts 0 and 1

Screening

for cohorts 2 to 8

Follow-Up 1

(all patients)

Follow-Up 2

(all patients)

Day

-7 to -4 before surgery

-14 to -2 before first RDT

12 weeks after firstadjuvant RT

6 months after firstadjuvant RT

Informed consent:

X

X

  

In- / Exclusion criteria:

X

X

  

MRI:

MRI outside screening period used for diagnosis and as baseline value

MRI up to 72 h after surgery, performed outside study protocol

Screening period used for diagnosis and baseline

X

X

Medical and neurological examination

X

X

X

X

Laboratory panel

X

X

X

X

Medical / surgical history

X

X