Using advanced MRI to predict treatment response in glioblastoma patients

Early Response Assessment Using on 3T Advanced MR Imaging as Predictor of Long-term Treatment Response in Newly Diagnosed Glioblastomas

This study tests if advanced MRI techniques can help doctors see how well treatment is working for people with newly diagnosed glioblastomas, so they can make better decisions about their care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Asan Medical Center (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Seoul)
• Trial ID: NCT02613988 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of advanced magnetic resonance imaging (MRI) techniques to assess early treatment responses in patients with newly diagnosed glioblastomas. The study focuses on multimodal imaging methods, including contrast-enhanced T1 weighted imaging, diffusion-weighted imaging, chemical exchange saturation transfer imaging, and perfusion imaging on a 3 Tesla MRI. By quantifying changes in these imaging techniques, the trial aims to predict long-term treatment outcomes and survival rates for patients undergoing standard chemoradiation therapy. This approach could help identify patients who may benefit from alternative treatment options earlier in their care.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with newly diagnosed glioblastoma who have measurable disease and are scheduled to receive standard treatment.

Not a fit: Patients who have undergone complete resection or have no measurable disease after surgery will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized treatment plans for glioblastoma patients, improving their chances of long-term survival.

How similar studies have performed: Other studies utilizing advanced imaging techniques have shown promise in predicting treatment responses, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* Patients must have radiologically and histologically confirmed diagnosis of newly diagnosed glioblastoma
* Patients must have measurable disease, defined as evident tumors with gadolinium enhancement on MRI that is measurable in at least one diameter
* Life expectancy of greater than 3 months
* Patients scheduled for standard therapy (6 weeks radiation treatment (RT) \~ 60 Gy, plus temozolomide 75 mg/m\^2 during 6 week RT, and followed routine monthly temozolomide therapy)
* 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 who underwent complete resection
* Patients with no evidence of measurable disease after surgery
* Patients who have had chemotherapy or radiotherapy
* Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction
* Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
* For patients who have undergone surgical resection prior to joining the study, in whom baseline magnetic resonance (MR) images exhibit enough signal degradation (due to susceptibility artifact in the region of the surgical bed) such that the data are uninterpretable will be excluded

Where this trial is running

Seoul

• Asan Medical Center — Seoul, South Korea (RECRUITING)

Study contacts

• Principal investigator: Ho Sung Kim, MD, PhD — Asan Medical Center
• Study coordinator: Ho Sung Kim, MD, PhD

Conditions: Adult Glioblastoma, Glioblastoma, MRI, standard treatment