FBY PET/CT in Patients With Brain Tumors

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03980431
• Other study ID #: PekingUMCH-FBY PET/CT
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

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.

Locations

Country	Name	City	State
China	Wenbin Ma	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Beijing Cancer Hospital, Peking University

Country where clinical trial is conducted

China, 

References & Publications (3)

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.

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. — View Citation

Röhrich M, Huang K, Schrimpf D, Albert NL, Hielscher T, von Deimling A, Schüller 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	standardized uptake value (SUV) for FBY	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.	1 week.
Secondary	Adverse events	Adverse event within 1 week after FBY injection will be documented.	1 week.