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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
Sponsor:
Collaborators:
Peking University
Peking University Cancer Hospital & Institute
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Brain Tumor Diagnostic Test: FBY PET Examination Not Applicable

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 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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 1 week. ]
    Adverse event within 1 week after FBY injection will be documented.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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   
Sponsors and Collaborators
Peking Union Medical College Hospital
Peking University
Peking University Cancer Hospital & Institute
More Information
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Publications:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking Union Medical College Hospital:
Brain Tumor
FBY-Positron Emission Computed Tomography (FBY-PET)
glioma
brain metastasis
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
 Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases