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Completed

NCT Number: NCT04143425

Response Prediction for Anti-angiogenic Treatment in Recurrent Glioblastoma

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

3-Tesla conventional magnetic resonance imaging

Diagnostic Test

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

Advanced imaging without contrast use

Diagnostic Test

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

Dynamic susceptibility contrast-weighted imaging

Diagnostic Test

Cerebral blood volume and vessel architectural imaging parameters

Primary outcomes

  1. Progression free survival

    Time frame: Average 9 months

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

Secondary outcomes

  1. 6-month progression

    Time frame: 6 month

    Pathologic confirmation following second look surgery or clinico-radiological assessment at 6-month

  2. Overall survival

    Time frame: Average 12 months

    Time from anti-angiogenic treatment to death

Sponsors and collaborators

Lead sponsor

Ho Sung Kim

Other

Registry information

Official study title

Prospective Observational Study of Imaging-based Response Prediction for Anti-angiogenic Treatment in Recurrent Glioblastomas

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 29, 2019
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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