Response Prediction for Anti-angiogenic Treatment in Recurrent Glioblastoma

February 6, 2020 updated by: Ho Sung Kim

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ji Eun Park, M.D.,Ph.D.
  • Phone Number: 82230101505
  • Email: jieunp@gmail.com

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients of tertiary medical center

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Received bevacizumab treatment
Recurrent glioblastoma patients with received anti-angiogenic treatment
Diagnostic test: 3-Tesla conventional magnetic resonance imaging
T1-weighted, T2-weighted, fluid-attenuated inversion recovery, and contrast-enhanced T1-weighted imaging
Diagnostic test: Advanced imaging without contrast use
Diffusion-weighted imaging, amide proton transfer-weighted imaging, electrical properties tomography, and 2hG-magnetic resonance spectroscopy
Diagnostic test: Dynamic susceptibility contrast-weighted imaging
Cerebral blood volume and vessel architectural imaging parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: Average 9 months
Time from anti-angiogenic treatment until death or the first imaging report indicating worsening/progression.
Average 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-month progression
Time Frame: 6 month
Pathologic confirmation following second look surgery or clinico-radiological assessment at 6-month
6 month
Overall survival
Time Frame: Average 12 months
Time from anti-angiogenic treatment to death
Average 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ho Sung Kim

Investigators

  • Principal Investigator: Ho Sung Kim, M.D.,Ph.D., Department of Radiology, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2020

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 27, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 29, 2019

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AsanMCHSKim_05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data sharing if raw imaging data outside Korea is prohibited by Korean government. For anonymized imaging data, part of cases may be feasible on the approval of the principle investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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