UNASSIGNED: This prospective clinical study aimed to compare the ICP changes (estimated by a non-invasive method based upon distortion product otoacoustic emissions (DPOAE) monitoring) with volume changes observed on MRI in patients with high-grade gliomas treated with radiotherapy. DPOAE measurements were performed one month after the end of radiotherapy and then every 3 months for one year. At each visit, the patient also underwent MRI as well as an evaluation of clinical signs.
UNASSIGNED: The variation in the estimate of intracranial pressure readout measured at each follow-up visit (in absolute value with respect to the baseline measurements) was significantly associated with the variation of T2/FLAIR volume (n=125; p<0.001) with a cut off value of change ICP readout of 40.2 degrees (e.i. an estimated change of 16 mm Hg).
UNASSIGNED: The GMaPIC trial confirm the hypothesis that the ICP change estimated by DPOAEs measurement using a non-invasive medical device is correlated with the change of the tumor or edema in high grade glioma after radiotherapy. The device could thus become an easy-to-use and non-invasive intracranial pressure monitoring tool for these patients.
UNASSIGNED: Clinicaltrials.gov, identifier (NCT02520492).
■这项前瞻性临床研究旨在比较ICP变化(通过基于畸变产物耳声发射(DPOAE)监测的非侵入性方法估算)与MRI上观察到的体积变化接受放射治疗的高级别神经胶质瘤。放疗结束后一个月进行DPOAE测量,然后每3个月进行一次,为期一年。每次访问,患者还接受了MRI检查以及临床体征评估.
■每次随访时测量的颅内压读数估计值的变化(相对于基线测量的绝对值)与T2/FLAIR体积的变化显着相关(n=125;p<0.001),ICP读数的变化截止值为40.2度(例如,估计的变化为16mmHg)。
■GMaPIC试验证实了以下假设:使用非侵入性医疗设备通过DPOAEs测量估计的ICP变化与放疗后高级别神经胶质瘤的肿瘤或水肿变化相关。因此,该设备可以成为这些患者的易于使用且无创的颅内压监测工具。
■Clinicaltrials.gov,标识符(NCT02520492)。