NCT04143425

Brief Summary

This study aims to evaluate whether pre-treatment MRI can be used to predict treatment response for anti-angiogenic treatment in glioblastomas.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

February 6, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

1.6 years

First QC Date

October 27, 2019

Last Update Submit

May 12, 2024

Conditions

Adult GlioblastomaMagnetic Resonance ImagingBevacizimab

Keywords

Recurrent Glioblastoma; Bevacizumab; Imaging

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    Time from anti-angiogenic treatment until death or the first imaging report indicating worsening/progression.

    Average 9 months

Secondary Outcomes (2)

  • 6-month progression

    6 month

  • Overall survival

    Average 12 months

Study Arms (1)

Received bevacizumab treatment

Recurrent glioblastoma patients with received anti-angiogenic treatment

Diagnostic Test: 3-Tesla conventional magnetic resonance imagingDiagnostic Test: Advanced imaging without contrast useDiagnostic Test: Dynamic susceptibility contrast-weighted imaging

Interventions

3-Tesla conventional magnetic resonance imagingDIAGNOSTIC_TEST

T1-weighted, T2-weighted, fluid-attenuated inversion recovery, and contrast-enhanced T1-weighted imaging

Received bevacizumab treatment
Advanced imaging without contrast useDIAGNOSTIC_TEST

Diffusion-weighted imaging, amide proton transfer-weighted imaging, electrical properties tomography, and 2hG-magnetic resonance spectroscopy

Received bevacizumab treatment
Dynamic susceptibility contrast-weighted imagingDIAGNOSTIC_TEST

Cerebral blood volume and vessel architectural imaging parameters

Received bevacizumab treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients of tertiary medical center

You may qualify if:

  • Patients had histologically confirmed glioblastoma with progression diagnosed on the basis of clinical data and MRI after standard treatment of operation, concurrent chemoradiotherapy, and adjuvant temozolomide;
  • Patients were more than 3 months from chemoradiotherapy to avoid the confounding factor of radiation necrosis (pseudoprogression);
  • Ability to understand and the willingness to sign a written informed consent document; all patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines

You may not qualify if:

  • Patients were not subject to therapies other than anti-angiogenic treatment, including re-operation, re-irradiation, or immunotherapies, because of the patient's clinical status and indication
  • Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (6)

  • Pope WB, Xia Q, Paton VE, Das A, Hambleton J, Kim HJ, Huo J, Brown MS, Goldin J, Cloughesy T. Patterns of progression in patients with recurrent glioblastoma treated with bevacizumab. Neurology. 2011 Feb 1;76(5):432-7. doi: 10.1212/WNL.0b013e31820a0a8a.

    PMID: 21282590BACKGROUND

  • Ellingson BM, Gerstner ER, Smits M, Huang RY, Colen R, Abrey LE, Aftab DT, Schwab GM, Hessel C, Harris RJ, Chakhoyan A, Gahrmann R, Pope WB, Leu K, Raymond C, Woodworth DC, de Groot J, Wen PY, Batchelor TT, van den Bent MJ, Cloughesy TF. Diffusion MRI Phenotypes Predict Overall Survival Benefit from Anti-VEGF Monotherapy in Recurrent Glioblastoma: Converging Evidence from Phase II Trials. Clin Cancer Res. 2017 Oct 1;23(19):5745-5756. doi: 10.1158/1078-0432.CCR-16-2844. Epub 2017 Jun 27.

    PMID: 28655794RESULT

  • Schmainda KM, Zhang Z, Prah M, Snyder BS, Gilbert MR, Sorensen AG, Barboriak DP, Boxerman JL. Dynamic susceptibility contrast MRI measures of relative cerebral blood volume as a prognostic marker for overall survival in recurrent glioblastoma: results from the ACRIN 6677/RTOG 0625 multicenter trial. Neuro Oncol. 2015 Aug;17(8):1148-56. doi: 10.1093/neuonc/nou364. Epub 2015 Feb 2.

    PMID: 25646027RESULT

  • Park JE, Kim HS, Park KJ, Kim SJ, Kim JH, Smith SA. Pre- and Posttreatment Glioma: Comparison of Amide Proton Transfer Imaging with MR Spectroscopy for Biomarkers of Tumor Proliferation. Radiology. 2016 Feb;278(2):514-23. doi: 10.1148/radiol.2015142979. Epub 2015 Aug 19.

    PMID: 26491847RESULT

  • Emblem KE, Mouridsen K, Bjornerud A, Farrar CT, Jennings D, Borra RJ, Wen PY, Ivy P, Batchelor TT, Rosen BR, Jain RK, Sorensen AG. Vessel architectural imaging identifies cancer patient responders to anti-angiogenic therapy. Nat Med. 2013 Sep;19(9):1178-83. doi: 10.1038/nm.3289. Epub 2013 Aug 18.

    PMID: 23955713RESULT

  • Kim M, Park JE, Yoon SK, Kim N, Kim YH, Kim JH, Kim HS. Vessel size and perfusion-derived vascular habitat refines prediction of treatment failure to bevacizumab in recurrent glioblastomas: validation in a prospective cohort. Eur Radiol. 2023 Jun;33(6):4475-4485. doi: 10.1007/s00330-022-09164-w. Epub 2022 Oct 15.

    PMID: 36242633DERIVED

Related Links

MeSH Terms

Conditions

Glioblastoma

Interventions

Perfusion Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Magnetic Resonance ImagingTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Ho Sung Kim, M.D.,Ph.D.

    Department of Radiology, Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 27, 2019

First Posted

October 29, 2019

Study Start

February 6, 2020

Primary Completion

August 31, 2021

Study Completion

November 1, 2022

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Data sharing if raw imaging data outside Korea is prohibited by Korean government. For anonymized imaging data, part of cases may be feasible on the approval of the principle investigator.

Available IPD Datasets

Clinical Study Report Access

Locations

KR(1)