Ignite Creation Date:
2024-05-06 @ 7:22 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05987098
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2023-08-03
Brief Title:
BBPA PETCT in Patients With Malignant Tumors
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Safety and Clinical Value of 18Fluorine-labeled BBPA PETCT in Patients With Malignant Tumors
Status:
RECRUITING
Status Verified Date:
2024-03
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:
This study is an open-labeled phase II diagnostic clinical trial to explore the safety and clinical value of BBPA-PETCT in suspected malignant tumor patients The investigation regarding the clinical value of BBPA concerning the metabolic characteristics of BBPA in suspected malignant tumors Quantitative features will be extracted to analysis the PET images For patient who took surgery after multiple examination histopathology molecular pathology and LAT-1 immunohistochemistry will also be obtained
Detailed Description:
In this study we utilized BBPA a novel boron amino acid which replaces the carboxyl group of 4-boronate phenylalanine BPA with a boron trifluoride group -BF3 -COOH as a diagnostic molecule for PET imaging of brain tumors is also a highly efficient boron carrier for BNCT Preclinical studies suggested 18FBBPA to be a pan-cancer probe that transmembrane transported through large neutral amino acid transporter type-1 LAT-1 However more studies and evidence are warranted to investigate the clinical value of BBPA PET imaging in human
This study aim to observe the safety of BBPA and investigate the diagnostic value of BBPA in the patient with suspected malignant tumors Patients who meet the eligibility criteria are included in clinical trials after fully communicating the condition explaining the benefits and risks of clinical trials clarifying the patients willingness to include the clinical trial and signing informed consent The cohort number BBPA administrative dose imaging protocols are decided based on the investigators preliminary data The diagnosis and post- examination treatment are based on the recommended guideline combined with the subjects own situation for standardized diagnosis and treatment
This study aim to observe the safety of BBPA and investigate the diagnostic value of BBPA in the patient with suspected malignant tumors Patients who meet the eligibility criteria are included in clinical trials after fully communicating the condition explaining the benefits and risks of clinical trials clarifying the patients willingness to include the clinical trial and signing informed consent The cohort number BBPA administrative dose imaging protocols are decided based on the investigators preliminary data The diagnosis and post- examination treatment are based on the recommended guideline combined with the subjects own situation for standardized diagnosis and treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None