We studied the effects on CSF dynamics at the foramen magnum and the clinical significance of the abnormal tonsillar motion in 14 patients with Chiari type I malformation and 14 control subjects using cine phase-contrast MRI. Dynamic MRI consisted of axial and sagittal cine phase-contrast sequences. CSF and tonsillar motion were qualitatively and quantitatively evaluated, and the subarachnoid space at the foramen magnum measured. In Chiari patients, cine phase-contrast MRI detected the abnormal pulsatile motion of the cerebellar tonsils, which produced a selective obstruction of CSF flow from the cranial cavity to the spine. The amplitude of the tonsillar pulsation and the severity of the arachnoid space reduction were associated with the symptom of cough-strain headache, but not with the presence of syringomyelia. The finding of abnormal valve dynamics of the cerebellar hernia revealed by cine phase-contrast MRI conforms to the pathophysiologic mechanisms suggested in pressure register studies and opens a new possibility in the presurgical assessment of Chiari patients with exertional symptoms.

Background: Concurrent chemotherapy and thoracic radiotherapy (CRT) followed by prophylactic cranial irradiation (PCI) is the standard strategy in limited stage small cell lung cancer (LS-SCLC). Methods: STIMULI is a 1:1 randomized phase II international trial aiming to demonstrate superiority of consolidation immunotherapy treatment (C) vs observation (O) after standard CRT and PCI, in patients (pts) with LS-SCLC. C consisted of four cycles of nivolumab (1 mg/kg, Q3W) plus ipilimumab (3 mg/kg, Q3W), followed by nivolumab monotherapy (240 mg, Q2W) for up to 12 months (m). The trial was designed to test two co-primary endpoints, progression-free survival (PFS) by RECIST 1.1 criteria, and overall survival (OS), at 1-sided alpha of 1% and 4%, respectively. Trial enrollment closed prematurely due to slow accrual, after half the initial sample size. The statistical analyses plan was updated to address PFS as primary endpoint to be tested at the full 5% 1-sided significance level. 81 PFS events were needed to achieve a power of 80% for testing an HR of 0.57. Secondary endpoints include OS, time to treatment failure (TTF), and safety.

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