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Brain TumorNCT03980431

FBY PET/CT in Patients With Brain Tumors

A study testing FBY PET Examination in people with Brain Tumor, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Tumor
What is being tested?
FBY PET Examination
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
1 May 2018to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Wenbin Ma

    Beijing, Beijing Municipality, 100005

    Wenbin Ma, M.D., +8613701364566, mawb2001@hotmail.com

    Yu Wang, M.D., +8615311860318, ywang@pumch.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Brain Tumor
Being tested
FBY PET Examination
Keywords
Brain Tumor, FBY-Positron Emission Computed Tomography (FBY-PET), glioma, brain metastasis
Medical subject headings
Brain Neoplasms, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FBY PET ExaminationDiagnostic test

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

Study groups in NCT03980431
Study groupRoleWhat they receive
FBY in suspected malignant brain tumorExperimentalThis 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.
Receives: Diagnostic Test: FBY PET Examination
FBY in suspected recurrent gliomaExperimentalThis 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.
Receives: Diagnostic Test: FBY PET Examination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 week.

Secondary outcomes (1)

  1. Adverse events

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

    Measured: 1 week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2019
  2. Study start1 May 2018
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
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)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03980431
Sponsor's protocol ID
PekingUMCH-FBY PET/CT
Status last verified
Nov 2020
First submitted
6 Jun 2019
Last updated
17 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30797715

  • 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.

    PubMed 29732524

  • 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.

  • 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.

    PubMed 33590273

Questions about this trial

What is this clinical trial studying?

A study testing FBY PET Examination in people with Brain Tumor, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

standardized uptake value (SUV) for FBY (time frame: 1 week.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03980431, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.

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