Table 1.
Pre- and post-treatment evaluation and assessment of efficacy
| Baseline | Treatment | Follow-up after | |||||
|---|---|---|---|---|---|---|---|
| Assessmenta | 1 M | 3 M | 6 M | Every 3 M thereafter | Every 6 M thereafter | ||
| Medical history | ✓ | ||||||
| Physical examination | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| CT or PET-CTb | ✓ | ||||||
| KPS | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| JCS | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| MMSE | ✓ | ✓ | ✓ | ||||
| Brain MRI | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Adverse events | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Footnotes: M Months, CT Computed tomography, PET-CT 18F-fluorodeoxyglucose positron emission tomography-computed tomography, KPS Karnofsky performance status, JCS Japan Coma Scale, MMSE Mini mental status examination, MRI Magnetic resonance imaging
aExtra imaging outside of the study schedule is allowed per the discretion of the physician
bEither enhanced CT or PET-CT is required