Bevacizumab treatment of intra-venous administration and diagnostic nuclear medicine for symptomatic radiation necrosis in the brai

Phase 2

• Conditions: Symptomatic radiation necrosis after radiotherapy for primary and metastatic brain tumors, and tumors of the adjacent tissues to the brain

• Registration Number: JPRN-UMIN000005391
• Lead Sponsor: Department of Neurosurgery, Osaka Medical College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-07
• Study Completion: 2014-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Patients are able to undertake necrotomy; Intracranial tumors are active and recurrent (L/N ratio on F-BPA-PET is greater than 2.5, or L/N ration on C-MET-PET is greater than 1.8; Patients require intravenous administration of antibiotics, antiviral drugs, and antifugal drugs for infection; Febrile patients more than 38 degree Celsius of body temperature or equal; Patients having severe comorbidities such as heart diseases, pulmonary fibrosis, interstitial pneumonia, hemorrhagic diathesis, uncontrollable hypertension or diabetes; *Comorbidity or history of unstable angina and myocardiac infarction within 6 months *Uncontrollable peptic ulcer *Uncontrollable hypertension *Unhealed advanced wound or fracture *Comorbidity or history of gastrointestinal perforation and fistula, and abdominal abscess within 6 months *Comorbidity or history of emoptysis and pulmonary hemorrhage greater than Grade 1 *Comorbidity or history of vascular diseases (venous and arterial thrombosis and embolism, aortic aneurysms) required interventions within 6 months *Congestive heart failure more than NYHA class I *Patients with a schedule of an operation during this study or patients having had an operation within 4 weeks; Patients with hemorrhage (intracranial hemorrhage, gastrointestinal hemorrhage, urinary hemorrhage, hemoptysis); PT-INR is greater than 2.5 or unstable when warfarinization; History of severe hypersensitivity or allergy to bevacizumab; Pregnant patients, patients with a possibility of pregnancy, or patients breastfeeding; Investigators judge patients who are inappropriate to include this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified