Status:
TERMINATED
Recurrent GBM With Maximal Neurosurgical Removal and Treatment With IORT
Lead Sponsor:
Parkridge Medical Center
Conditions:
Glioblastoma
GBM
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the safety and efficacy of the Xoft Axxent eBx System when used for single-fraction IORT for recurrent Glioblastoma. IORT using the Xoft Axxent eBx System is no ...
Detailed Description
Device Description: The Xoft Axxent Electronic Brachytherapy System is a device that delivers radiation at a high dose rate. It is designed for use with Axxent applicators to treat lesions, tumors, an...
Eligibility Criteria
Inclusion
- Potentially-resectable, histologically proven recurrent GBM
- Subject must be ≥ 18 years of age
- Subject must have a Karnofsky Performance Score ≥ 70%
- Subject must have had a T1 weighted 3D MRI with Gadolinium enhancement within fourteen (14) days prior to surgery
- Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment
- Subjects of child-bearing potential must agree to use adequate contraceptive precautions and not to breastfeed (if applicable)
Exclusion
- More than three relapses
- Subject has multi-centric disease
- Subject has tumors in or near (less than 10mm from tumor margin) critical brain structures, that would exclude sufficient dose delivery to the tumor: such as:
- Optic Chiasm
- Optic Nerve
- Women who are pregnant or nursing. Women with child-bearing potential or sexually active men that are not willing/able to use medically acceptable forms of contraception
- Subject has contraindications for MRI with or without gadolinium injections
- Subject has contraindications for anesthesia or surgery
- Subject is on another therapeutic clinical trial concurrently
- Subject had previous radiation for GBM less than 3 month earlier
- Prior history of standard dose of Central Nervous System (CNS) of more than 60 Gy
- Intra-Operative Exclusion Criteria
- Frozen section does not show any sign of malignant tissue
- Dose at any organ at risk will exceed 10 Gy including:
- Chiasm
- Optic Nerve
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04763031
Start Date
March 5 2021
End Date
November 3 2023
Last Update
November 9 2023
Active Locations (1)
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1
Parkridge Medical Center - Neurosurgery
Chattanooga, Tennessee, United States, 37404