Response Prediction for Anti-angiogenic Treatment in Recurrent Glioblastoma

NCT ID: NCT04143425

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-06

Study Completion Date

2022-11-01

Brief Summary

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

Detailed Description

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Although overall the effects on prolonging survival in bevacizumab-treated patients is modest at best, it is still unclear whether there is not a more substantial positive effect in a subset of patients, potentially identifiable by imaging markers. Allowing for prediction of good or bad responder from anti-angiogenic therapy prior to treatment completion is important to select patients most likely to benefit from anti-angiogenic treatment.

This is a prospective observational study and no active comparator will be used. Study participants include adult patients with recurrent glioblastoma.

We hypothesized that quantifying changes in multi-modal advanced MR imaging techniques would allow early treatment response and long-term prediction in glioblastomas.

Conditions

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Adult Glioblastoma Magnetic Resonance Imaging Bevacizimab

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Received bevacizumab treatment

Recurrent glioblastoma patients with received anti-angiogenic treatment

3-Tesla conventional magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

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

Advanced imaging without contrast use

Intervention Type DIAGNOSTIC_TEST

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

Dynamic susceptibility contrast-weighted imaging

Intervention Type DIAGNOSTIC_TEST

Cerebral blood volume and vessel architectural imaging parameters

Interventions

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3-Tesla conventional magnetic resonance imaging

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

Intervention Type DIAGNOSTIC_TEST

Advanced imaging without contrast use

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

Intervention Type DIAGNOSTIC_TEST

Dynamic susceptibility contrast-weighted imaging

Cerebral blood volume and vessel architectural imaging parameters

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. 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;
2. Patients were more than 3 months from chemoradiotherapy to avoid the confounding factor of radiation necrosis (pseudoprogression);
3. 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

Exclusion Criteria

1. 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
2. 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ho Sung Kim

OTHER

Sponsor Role lead

Responsible Party

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Ho Sung Kim

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ho Sung Kim, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Radiology, Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 21282590 (View on PubMed)

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.

Reference Type RESULT
PMID: 28655794 (View on PubMed)

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.

Reference Type RESULT
PMID: 25646027 (View on PubMed)

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.

Reference Type RESULT
PMID: 26491847 (View on PubMed)

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.

Reference Type RESULT
PMID: 23955713 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36242633 (View on PubMed)

Study Documents

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Document Type: Clinical Study Report

Vessel size and perfusion-derived vascular habitat refines prediction of treatment failure to bevacizumab in recurrent glioblastomas: validation in a prospective cohort

View Document

Related Links

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Other Identifiers

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AsanMCHSKim_05

Identifier Type: -

Identifier Source: org_study_id

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