Following our pilot clinical study of combined IL-2/HSV-TK gene therapy for recurrent glioblastoma multiforme (GBM), we extended the protocol to a larger population of patients and evaluated safety, feasibility, and biological activity of treatment. A total of 12 patients received intratumor injection of retroviral vector-producing cells (RVPCs), followed by intravenous ganciclovir (GCV). Treatment was well tolerated with only minor adverse events. Transduction of tumor cells was demonstrated in tumor biopsies. A marked and persistent increase of intratumor and plasma Th1 cytokine levels was demonstrated after RVPC injection. At magnetic resonance imaging evaluation, two patients had a partial response (including a patient showing disappearance of a distant noninjected tumor mass), four had a minor response, four had stable disease, and two had progressive disease. The 6- and 12-month progression-free survival rates were 47 and 14%, respectively. The 6- and 12-month overall survival rates were 58 and 25%, respectively. In conclusion, the results of our clinical protocol of gene therapy for recurrent GBM, based on combined delivery of a suicide and a cytokine gene, demonstrate that intratumor injection of RVPCs was safe, provided effective transduction of the therapeutic genes to target tumor cells, and activated a systemic cytokine cascade, with tumor responses in 50% of cases.
This is the first report describing a technique developed for CyberKnife radiosurgery of cerebral AVMs. The use of different imaging modalities for automatic delineation of the target and critical structures combined with the employment of the inverse treatment planning capability is the crucial point of the procedure. The procedure proved to be safe and efficient.
The evaluation of patients with symptoms recurrent after disc surgery is a difficult diagnostic problem. The most common causes are recurrent herniation and postoperative scarring; routine x-ray and myelographic differentiation between herniation and scarring is difficult or impossible. High resolution computed tomography (CT) has shown some results in the evaluation of postoperative patients, but the role of epidural fibrosis in failed back surgery syndrome (FBSS) is not clear. Some knowledge of the "normal" CT physiological healing and scarring after disc surgery is necessary. We scanned 20 asymptomatic operated patients and 20 patients with recurrent sciatic nerve pain after disc surgery who did not have bony stenosis, recurrent disc herniation, or other causes of FBSS. Our observations showed no important differences in the fibrosis demonstrated by CT between symptomatic and asymptomatic patients. The degree and type of fibrosis are not related to recurrent symptoms.
30 patients on hemodialysis or peritoneal dialysis have been investigated by computerized tomographic (CT) scan. To evaluate possible cerebral alterations induced by dialysis, CT examinations were carried out before, immediately after and 6 h after the end of dialysis with an Evaluskop, which provides an objective precise evaluation of even slight variations in brain density. No morphological variations were noted after dialysis, while the brain density fell significantly during and after the treatment. A decrease in density was not observed in normal subjects or in patients on continuous peritoneal dialysis. The changes in the densitometric values of brain tissue suggest that there is a postdialysis gain in cerebral water linked to the intermittent treatment. CT may represent a simple reliable method for studying uremic encephalopathy and investigating the pathogenesis of the dialysis disequilibrium syndrome.
Background and Purpose— As a reliable scoring system to detect the risk of symptomatic intracerebral hemorrhage after thrombectomy for ischemic stroke is not yet available, we developed a nomogram for predicting symptomatic intracerebral hemorrhage in patients with large vessel occlusion in the anterior circulation who received bridging of thrombectomy with intravenous thrombolysis (training set), and to validate the model by using a cohort of patients treated with direct thrombectomy (test set). Methods— We conducted a cohort study on prospectively collected data from 3714 patients enrolled in the IER (Italian Registry of Endovascular Stroke Treatment in Acute Stroke). Symptomatic intracerebral hemorrhage was defined as any type of intracerebral hemorrhage with increase of ≥4 National Institutes of Health Stroke Scale score points from baseline ≤24 hours or death. Based on multivariate logistic models, the nomogram was generated. We assessed the discriminative performance by using the area under the receiver operating characteristic curve. Results— National Institutes of Health Stroke Scale score, onset-to-end procedure time, age, unsuccessful recanalization, and Careggi collateral score composed the IER-SICH nomogram. After removing Careggi collateral score from the first model, a second model including Alberta Stroke Program Early CT Score was developed. The area under the receiver operating characteristic curve of the IER-SICH nomogram was 0.778 in the training set (n=492) and 0.709 in the test set (n=399). The area under the receiver operating characteristic curve of the second model was 0.733 in the training set (n=988) and 0.685 in the test set (n=779). Conclusions— The IER-SICH nomogram is the first model developed and validated for predicting symptomatic intracerebral hemorrhage after thrombectomy. It may provide indications on early identification of patients for more or less postprocedural intensive management.
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