FBY PET/CT in Patients With Brain Tumors
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|ClinicalTrials.gov Identifier: NCT03980431|
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor||Diagnostic Test: FBY-PET Examination Group: Patients receive FBY-PET examination after entrance||Not Applicable|
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, prognostic, predictive performance 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 patient's 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 subject's own situation for standardized diagnosis and treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A single dose of 0.15 mCi/kg FBY will be intravenously injected and PET examination will carry out 30 minutes later.|
|Masking:||None (Open Label)|
|Official Title:||Safety and Clinical Value of 18Fluorine-labeled Boron Tyrosine PET/CT in Patients With Brain Tumors|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
|Experimental: FBY-PET Group||
Diagnostic Test: FBY-PET Examination Group: Patients receive FBY-PET examination after entrance
A single dose of 0.15 mCi/kg FBY will be intravenously injected and PET examination will carry out 30 minutes later.
- standardized uptake value (SUV) for FBY [ Time Frame: 1 week. ]SUV reflects the uptake of PET tracers, and quantitative imaging features such as SUVmax, SUVmean, and visually-assessed features will be measured in the evaluation of tumors.
- Adverse events [ Time Frame: 1 week. ]Adverse event within 1 week after FBY injection will be documented.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980431
|Beijing, Beijing, China, 100005|
|Contact: Wenbin Ma, M.D. +8613701364566 email@example.com|
|Contact: Yu Wang, M.D. +8615311860318 firstname.lastname@example.org|