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FBY PET/CT in Patients With Brain Tumors

Primary Purpose

Brain Tumor

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

FBY PET Examination

About this trial

This is an interventional diagnostic trial for Brain Tumor focused on measuring Brain Tumor, FBY-Positron Emission Computed Tomography (FBY-PET), glioma, brain metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Wenbin MaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

FBY in suspected malignant brain tumor

FBY in suspected recurrent glioma

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse events

Adverse event within 1 week after FBY injection will be documented.

Full Information

NCT ID

NCT03980431

First Posted

June 6, 2019

Last Updated

November 16, 2020

Sponsor

Peking Union Medical College Hospital

Collaborators

Peking University, Peking University Cancer Hospital & Institute

1. Study Identification

Unique Protocol Identification Number

NCT03980431

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2018 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

Collaborators

Peking University, Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Tumor

Keywords

Brain Tumor, FBY-Positron Emission Computed Tomography (FBY-PET), glioma, brain metastasis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FBY in suspected malignant brain tumor

Arm Type

Experimental

Arm Description

Arm Title

FBY in suspected recurrent glioma

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

FBY PET Examination

Intervention Description

A single dose of 0.10 mCi/kg FBY will be intravenously injected and PET examination will carry out 30 minutes later.

Primary Outcome Measure Information:

Title

standardized uptake value (SUV) for FBY

Description

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.

Time Frame

1 week.

Secondary Outcome Measure Information:

Title

Adverse events

Description

Adverse event within 1 week after FBY injection will be documented.

Time Frame

1 week.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Wenbin Ma

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100005

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wenbin Ma, M.D.

Phone

+8613701364566

mawb2001@hotmail.com

First Name & Middle Initial & Last Name & Degree

Yu Wang, M.D.

Phone

+8615311860318

ywang@pumch.cn

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30797715

Citation

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.

Results Reference

background

PubMed Identifier

29732524

Citation

Rohrich M, Huang K, Schrimpf D, Albert NL, Hielscher T, von Deimling A, Schuller 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.

Results Reference

background

Citation

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.

Results Reference

background

PubMed Identifier

33590273

Citation

Li Z, Kong Z, Chen J, Li J, Li N, Yang Z, Wang Y, Liu Z. 18F-Boramino acid PET/CT in healthy volunteers and glioma patients. Eur J Nucl Med Mol Imaging. 2021 Sep;48(10):3113-3121. doi: 10.1007/s00259-021-05212-7. Epub 2021 Feb 15.

Results Reference

derived

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FBY PET/CT in Patients With Brain Tumors

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