Ignite Creation Date:
2024-05-06 @ 1:18 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03980431
Status:
UNKNOWN
Last Update Posted:
2020-11-17
First Post:
2019-06-06
Brief Title:
FBY PETCT in Patients With Brain Tumors
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Safety and Clinical Value of 18Fluorine-labeled Boron Tyrosine PETCT in Patients With Brain Tumors
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
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 FBY in suspected adult brain tumor patients The investigation regarding the clinical value of FBY includes 1 the metabolic characteristics of FBY in suspected malignant brain tumors 2 role of FBY to differentiate tumor progression from pseudoprogression A single dose of 010 mCikg FBY will be intravenously injected for PET examination Quantitative features will be extracted to analysis the PET images Cranial MRI with contrast enhancement will also performed as diagnostic comparison with FBY For patient who took surgery after multiple examination histopathology molecular pathology and LAT-1 immunohistochemistry will also be obtained
Detailed Description:
FBY is a new PET tracer derived from tyrosine with the carboxyl group replaced by boron trifluoride and is transferred across cell membrane through LAT-1 LAT-1 is a sodium independent amino acid transporter and is highly expressed in tumor cells Considering the significant role in cancer development as well as in nutrient delivery FBY could be a promising PET tracer to reflect altered metabolism in tumors
This study aim to observe the safety of FBY and investigate the diagnostic value of FBY in the patient with suspected brain 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 FBY 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 FBY and investigate the diagnostic value of FBY in the patient with suspected brain 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 FBY 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