Response Prediction for Anti-angiogenic Treatment in Recurrent Glioblastoma

Completed

• Conditions: Bevacizimab; Magnetic Resonance Imaging; Adult Glioblastoma
• Interventions: Diagnostic Test: 3-Tesla conventional magnetic resonance imaging; Diagnostic Test: Advanced imaging without contrast use; Diagnostic Test: Dynamic susceptibility contrast-weighted imaging

• Registration Number: NCT04143425
• Lead Sponsor: Ho Sung Kim

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.

Study Timeline

• Study First Submitted: 2019-10-27
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-29
• Study Start: 2020-02-06
• Primary Completion: 2021-08-31
• Study Completion: 2022-11-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-12
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Received bevacizumab treatment	3-Tesla conventional magnetic resonance imaging	Recurrent glioblastoma patients with received anti-angiogenic treatment
Received bevacizumab treatment	Advanced imaging without contrast use	Recurrent glioblastoma patients with received anti-angiogenic treatment
Received bevacizumab treatment	Dynamic susceptibility contrast-weighted imaging	Recurrent glioblastoma patients with received anti-angiogenic treatment

Primary Outcome Measures

Name	Time	Method
Progression free survival	Average 9 months	Time from anti-angiogenic treatment until death or the first imaging report indicating worsening/progression.

Secondary Outcome Measures

Name	Time	Method
Overall survival	Average 12 months	Time from anti-angiogenic treatment to death
6-month progression	6 month	Pathologic confirmation following second look surgery or clinico-radiological assessment at 6-month

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of