FBY PET/CT in Patients With Brain Tumors

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Brief Title

FBY PET/CT in Patients With Brain Tumors

Official Title

Safety and Clinical Value of 18Fluorine-labeled Boron Tyrosine PET/CT in Patients With Brain Tumors

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.
    

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 Type

Interventional


Primary Outcome

standardized uptake value (SUV) for FBY

Secondary Outcome

 Adverse events

Condition

Brain Tumor

Intervention

FBY PET Examination

Study Arms / Comparison Groups

 FBY in suspected malignant brain tumor
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

50

Start Date

May 1, 2018

Completion Date

December 31, 2021

Primary Completion Date

December 31, 2021

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03980431

Organization ID

PekingUMCH-FBY PET/CT


Responsible Party

Sponsor

Study Sponsor

Peking Union Medical College Hospital

Collaborators

 Peking University

Study Sponsor

, , 


Verification Date

November 2020