Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603987
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Using CICS-1 and SPM-011 and 18FFBPA Commissioned by CICS and Sumitomo Heavy Industries and STELLA PHARMA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase III Basket Trial Boron Neutron Capture Therapy BNCT Using CICS-1 and SPM-011 for Patients with Recurrent Solid Malignant Thoracic Tumors That Are Unresectable and Perceived Challenging to Treat with Standard Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety and efficacy of Boron Neutron Capture Therapy BNCT in patients with recurrent thoracic solid tumors that are difficult to treat with standard radiation therapy or drug therapy and are unresectable With lung heart liver spinal cord and esophagus as common risk organs in the treatment plan for BNCT using therapeutic CT to evaluate the safety and efficacy of BNCT in patients with unresectable and recurrent thoracic solid tumors which are difficult to treat with standard radiation and drug therapy
To evaluate the safety of 18FFBPA synthesized with MPS200FBPA In addition the usefulness of 18FFBPA-PET testing to determine the appropriateness of performing BNCT will be evaluated in an exploratory manner
To evaluate the safety of 18FFBPA synthesized with MPS200FBPA In addition the usefulness of 18FFBPA-PET testing to determine the appropriateness of performing BNCT will be evaluated in an exploratory manner
Detailed Description:
None
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