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 : November 17, 2020
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Condition or disease | Intervention/treatment | Phase |
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Brain Tumor | Diagnostic Test: FBY PET Examination | 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 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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | A single dose of 0.10 mCi/kg FBY will be intravenously injected and PET examination will carry out 30 minutes later. |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Safety and Clinical Value of 18Fluorine-labeled Boron Tyrosine PET/CT in Patients With Brain Tumors |
Actual Study Start Date : | May 1, 2018 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2021 |

Arm | Intervention/treatment |
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Experimental: 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.
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Diagnostic Test: 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. |
Experimental: 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.
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Diagnostic Test: 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. |
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 1. Have suspected diagnosis of brain tumors, based on clinical performance and MRI results.
- 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:
- 1. Have a history of imaging agent allergies;
- 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.

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
China, Beijing | |
Wenbin Ma | Recruiting |
Beijing, Beijing, China, 100005 | |
Contact: Wenbin Ma, M.D. +8613701364566 mawb2001@hotmail.com | |
Contact: Yu Wang, M.D. +8615311860318 ywang@pumch.cn |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Peking Union Medical College Hospital |
ClinicalTrials.gov Identifier: | NCT03980431 |
Other Study ID Numbers: |
PekingUMCH-FBY PET/CT |
First Posted: | June 10, 2019 Key Record Dates |
Last Update Posted: | November 17, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Brain Tumor FBY-Positron Emission Computed Tomography (FBY-PET) glioma brain metastasis |
Brain Neoplasms Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms |
Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |