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Response Prediction for Anti-angiogenic Treatment in Recurrent Glioblastoma

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04143425
Enrollment
15
Registered
2019-10-29
Start date
2020-02-06
Completion date
2022-11-01
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Glioblastoma, Bevacizimab, Magnetic Resonance Imaging

Keywords

Recurrent Glioblastoma; Bevacizumab; Imaging

Brief summary

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

Detailed description

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.

Interventions

DIAGNOSTIC_TEST3-Tesla conventional magnetic resonance imaging

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

DIAGNOSTIC_TESTAdvanced imaging without contrast use

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

DIAGNOSTIC_TESTDynamic susceptibility contrast-weighted imaging

Cerebral blood volume and vessel architectural imaging parameters

Sponsors

Ho Sung Kim
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Progression free survivalAverage 9 monthsTime from anti-angiogenic treatment until death or the first imaging report indicating worsening/progression.

Secondary

MeasureTime frameDescription
6-month progression6 monthPathologic confirmation following second look surgery or clinico-radiological assessment at 6-month
Overall survivalAverage 12 monthsTime from anti-angiogenic treatment to death

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026