Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114790
Status:
COMPLETED
Last Update Posted:
2013-05-06
First Post:
2005-06-17
Brief Title:
Boronophenylalanine BPA-Based Boron Neutron Capture Therapy BNCT in the Treatment Head and Neck Tumors
Sponsor:
Boneca Corporation
Organization:
Boneca Corporation
Study Overview
Official Title:
Boronophenylalanine BPA-Based Boron Neutron Capture Therapy BNCT in the Treatment of Inoperable and Irradiated Head and Neck Tumors A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Boron Neutron Capture Therapy BNCT is an experimental radiation therapy technique which is based on the principle of irradiating boron atoms with neutrons When neutrons have relatively low energy boron atoms that have been targeted to cancerous tissue using a suitable boron carrier an amino acid derivative called BPA boronophenylalanine will capture the neutrons As a result from the neutron capture the boron atoms will split into two producing helium and lithium ions The helium and lithium ions in turn have only a short pathlength in tissue about 5 micrometers and will deposit their cell damaging effect mainly within the tumor provided that the boron carrier BPA has accumulated in the tumor In practice the study participants will receive BPA as an approximately 2-hour intravenous infusion following which the tumor is irradiated with low energy epithermal neutrons obtained from a nuclear reactor at the BNCT facility BNCT requires careful radiation dose planning but neutron irradiation will last approximately only for one hour In this study BNCT will be repeated and the 2 treatments will be given 3 to 5 weeks apart The study hypothesis is that head and neck cancers that have recurred following conventional radiotherapy might accumulate the boron carrier compound and might respond to BNCT
Detailed Description:
This is a single BNCT-facility non-randomized non-comparative open-label phase I to II trial to determine the value of BNCT in the treatment of inoperable irradiated locally advanced cancers of the head and neck region An attempt to perform 18F-labeled boronophenylalanine 18F-BPA SPECT or PET imaging will be made before BNCT Patients whose tumor uptake is 25 times that of the corresponding normal head and neck tissue will be enrolled and treated with a single fraction BPA-based BNCT twice 3 to 5 weeks apart Another 18F-BPA SPECT or PET study may be performed 1 to 3 months after BNCT to determine the SPECTPET response
The neutron irradiation site is the FiR 1 reactor site located at Otaniemi Espoo Finland about 6 kilometers from the Helsinki University Central Hospital Helsinki where patient evaluation and post-irradiation care will take place
Prior to BNCT BPA is infused as a fructose complex l-BPA-F into a peripheral vein over 2 hours Blood samples will be taken for monitoring whole blood boron concentration before starting the BPA infusion and thereafter at 20 to 40 minute intervals during the infusion following infusion and after delivering neutron irradiation The blood samples will be analyzed for blood boron concentration to estimate the average blood boron concentration during neutron irradiation
All patients will be evaluated for response using CT or magnetic resonance imaging MRI
The neutron irradiation site is the FiR 1 reactor site located at Otaniemi Espoo Finland about 6 kilometers from the Helsinki University Central Hospital Helsinki where patient evaluation and post-irradiation care will take place
Prior to BNCT BPA is infused as a fructose complex l-BPA-F into a peripheral vein over 2 hours Blood samples will be taken for monitoring whole blood boron concentration before starting the BPA infusion and thereafter at 20 to 40 minute intervals during the infusion following infusion and after delivering neutron irradiation The blood samples will be analyzed for blood boron concentration to estimate the average blood boron concentration during neutron irradiation
All patients will be evaluated for response using CT or magnetic resonance imaging MRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None