FBY PET/CT in Patients With Brain Tumors

Not Applicable

• Conditions: Brain Tumor
• Interventions: Diagnostic Test: FBY PET Examination

• Registration Number: NCT03980431
• Lead Sponsor: Peking Union Medical College Hospital

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 Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-17
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FBY in suspected recurrent glioma	FBY PET Examination	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 in suspected malignant brain tumor	FBY PET Examination	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.

Primary Outcome Measures

Name	Time	Method
standardized uptake value (SUV) for FBY	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

Name	Time	Method
Adverse events	1 week.	Adverse event within 1 week after FBY injection will be documented.

Trial Locations

Locations (1)

Wenbin Ma; 🇨🇳 Beijing, Beijing, China