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Clinical Trial 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 0.10 mCi/kg 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.


Clinical Trial 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 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 Design


Related Conditions & MeSH terms


NCT number NCT03980431
Study type Interventional
Source Peking Union Medical College Hospital
Contact
Status Recruiting
Phase N/A
Start date May 1, 2018
Completion date December 31, 2021

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