NCT03980431

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

3.7 years

First QC Date

June 6, 2019

Last Update Submit

November 16, 2020

Conditions

Brain Tumor

Keywords

Brain TumorFBY-Positron Emission Computed Tomography (FBY-PET)gliomabrain metastasis

Outcome Measures

Primary Outcomes (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.

    1 week.

Secondary Outcomes (1)

  • Adverse events

    1 week.

Study Arms (2)

FBY in suspected malignant brain tumor

EXPERIMENTAL

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.

Diagnostic Test: FBY PET Examination

FBY in suspected recurrent glioma

EXPERIMENTAL

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.

Diagnostic Test: FBY PET Examination

Interventions

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.

FBY in suspected malignant brain tumorFBY in suspected recurrent glioma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Have suspected diagnosis of brain tumors, based on clinical performance and MRI results.
  • \. Meet the indications for PET examination, show a clear indication and no contraindications;
  • \. Have a performance status of score ≥70 on KPS scale or score 0-1 points on ECOG scale, a relatively good general situation;
  • 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;
  • \. Be ≥ 18 years of age on day of signing informed consent.
  • \. Be willing and able to understand the research content and provide written informed consent/assent for the trial.

You may not qualify if:

  • \. Have a history of imaging agent allergies;
  • \. Does not meet the PET-CT scan sedation requirements, or there are contraindications for PET-CT examination;
  • \. Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial;
  • \. Unable to adhere strictly to protocol requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wenbin Ma

Beijing, Beijing Municipality, 100005, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 30797715BACKGROUND

  • 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.

    PMID: 29732524BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 33590273DERIVED

MeSH Terms

Conditions

Brain NeoplasmsGlioma

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: A single dose of 0.10 mCi/kg FBY will be intravenously injected and PET examination will carry out 30 minutes later.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2019

First Posted

June 10, 2019

Study Start

May 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

November 17, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)