Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2018-05-01
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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FBY in suspected malignant brain tumor
This arm investigates the metabolic characteristics of FBY in suspected malignant brain tumor patients who consider for surgical operations. A single dose of 0.10 mCi/kg FBY will be intravenously injected and PET examination will carry out 30 minutes later. Surgical operations, if recommended after multiple examination, will be carried out within 1 week after FBY PET scan.
FBY PET Examination
A single dose of 0.10 mCi/kg FBY will be intravenously injected and PET examination will carry out 30 minutes later.
FBY in suspected recurrent glioma
This arm investigates the value of FBY to differentiate tumor progression from pseudoprogression. A single dose of 0.10 mCi/kg FBY will be intravenously injected and PET examination will carry out 30 minutes later. Surgical operation, MRI follow up or change of treatment strategy, according to specific conditions, will be recommended for the definitive diagnosis as well as the management of patients.
FBY PET Examination
A single dose of 0.10 mCi/kg FBY will be intravenously injected and PET examination will carry out 30 minutes later.
Interventions
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FBY PET Examination
A single dose of 0.10 mCi/kg FBY will be intravenously injected and PET examination will carry out 30 minutes later.
Eligibility Criteria
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Inclusion Criteria
* 2\. Meet the indications for PET examination, show a clear indication and no contraindications;
* 3\. Have a performance status of score ≥70 on KPS scale or score 0-1 points on ECOG scale, a relatively good general situation;
* 4 Does not appear agonal stage, deep coma, over grade 2 major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection;
* 5\. Be ≥ 18 years of age on day of signing informed consent.
* 6\. Be willing and able to understand the research content and provide written informed consent/assent for the trial.
Exclusion Criteria
* 2\. Does not meet the PET-CT scan sedation requirements, or there are contraindications for PET-CT examination;
* 3\. Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial;
* 4\. Unable to adhere strictly to protocol requirements.
18 Years
ALL
No
Sponsors
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Peking University
OTHER
Peking University Cancer Hospital & Institute
OTHER
Peking Union Medical College Hospital
OTHER
Responsible Party
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Locations
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Wenbin Ma
Beijing, Beijing Municipality, China
Countries
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Facility Contacts
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Wenbin Ma, M.D.
Role: primary
Yu Wang, M.D.
Role: backup
References
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GBD 2016 Brain and Other CNS Cancer Collaborators. Global, regional, and national burden of brain and other CNS cancer, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 Apr;18(4):376-393. doi: 10.1016/S1474-4422(18)30468-X. Epub 2019 Feb 21.
Rohrich M, Huang K, Schrimpf D, Albert NL, Hielscher T, von Deimling A, Schuller U, Dimitrakopoulou-Strauss A, Haberkorn U. Integrated analysis of dynamic FET PET/CT parameters, histology, and methylation profiling of 44 gliomas. Eur J Nucl Med Mol Imaging. 2018 Jul;45(9):1573-1584. doi: 10.1007/s00259-018-4009-0. Epub 2018 May 7.
Chansaenpak K, Wang M, Wang H, et al. Preparation of [18F]-NHC-BF3 conjugates and their applications in PET imaging. RSC Advances, 2017, 7(29): 17748-17751.
Li Z, Kong Z, Chen J, Li J, Li N, Yang Z, Wang Y, Liu Z. 18F-Boramino acid PET/CT in healthy volunteers and glioma patients. Eur J Nucl Med Mol Imaging. 2021 Sep;48(10):3113-3121. doi: 10.1007/s00259-021-05212-7. Epub 2021 Feb 15.
Other Identifiers
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PekingUMCH-FBY PET/CT
Identifier Type: -
Identifier Source: org_study_id