Response Prediction for Anti-angiogenic Treatment in Recurrent Glioblastoma

Ho Sung Kim

Status: Completed

Conditions: Adult Glioblastoma; Bevacizimab; Magnetic Resonance Imaging

Treatments: Diagnostic Test: 3-Tesla conventional magnetic resonance imaging; Diagnostic Test: Advanced imaging without contrast use; Diagnostic Test: Dynamic susceptibility contrast-weighted imaging

Study type: Observational

Funder types: Other

Identifiers

NCT04143425

AsanMCHSKim_05

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

Received bevacizumab treatment

Description:

Recurrent glioblastoma patients with received anti-angiogenic treatment

Treatment:

Diagnostic Test: Dynamic susceptibility contrast-weighted imaging

Diagnostic Test: 3-Tesla conventional magnetic resonance imaging

Diagnostic Test: Advanced imaging without contrast use