RS-fMRI for Cognitive Changes in Brain Tumor Patients

Recruiting at 1 trial location

Overseen By Jiayi Huang, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Prior cranial RT, Metastatic involvement, MRI contraindication, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how radiation therapy affects cognitive abilities in patients with certain brain tumors. Researchers aim to identify which brain networks are most at risk of damage leading to cognitive decline by using a special type of MRI. The goal is to improve future treatment plans and protect brain function during radiation therapy. Suitable candidates include individuals diagnosed with specific types of brain tumors, such as IDH-mutant astrocytoma or oligodendroglioma, who plan to undergo radiation therapy. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in brain tumor care.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, you can participate in other clinical trials and receive chemotherapy or experimental agents concurrently with or after radiation therapy, as long as those trials allow it.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that radiation therapy, including advanced methods like proton beam or intensity-modulated radiation therapy, is usually well-tolerated for treating brain tumors such as gliomas. However, some risks are involved. Studies have found that patients might experience side effects, such as an increased risk of blood flow problems in the brain, after receiving radiation treatment. It is important to weigh these risks against the potential benefits of the treatment.

Radiation therapy is a common approach for brain tumors, but monitoring for any negative effects is essential. Patients with a specific type of glioma, called IDH-mutated gliomas, often respond well to treatment and can live for several years. This suggests that the treatment can be effective despite the risks. Anyone considering joining a clinical trial should discuss possible side effects with their doctor to make an informed decision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it could reveal how radiation therapy affects cognitive changes in patients with IDH-mutant and IDH-wildtype gliomas. Unlike typical treatment assessments that focus solely on tumor response, this study uses advanced imaging techniques, like resting-state functional MRI (RS-fMRI), to monitor brain networks over an extended period, up to ten years. This approach may offer insights into long-term cognitive effects and help tailor future therapies to preserve brain function while effectively treating tumors.

What evidence suggests that this trial's treatments could be effective for neurocognitive decline after radiation therapy?

This trial will examine the effects of radiation therapy on various brain tumors, including IDH-mutant astrocytoma or oligodendroglioma, IDH-wildtype astrocytoma, and benign brain tumors. Studies have shown that radiation therapy effectively treats gliomas, particularly those with IDH mutations. These mutations frequently appear in certain brain tumors and often affect younger adults. Research indicates that patients with IDH-mutant gliomas usually respond well to treatment, with many living more than ten years after diagnosis. Carefully planned radiation therapy can target the tumor while minimizing harm to nearby healthy brain tissue, thus better preserving thinking and memory skills compared to older methods. This approach shows promise in maintaining cognitive abilities while effectively treating the tumor. ^{3 5 6 7 8}

Who Is on the Research Team?

Jiayi Huang, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

Able to understand and willing to sign an IRB-approved written informed consent document (legally authorized representative permitted).

Cohort A: histological diagnosis of IDH-mutant astrocytoma or oligodendroglioma, WHO grade II-IV. IDH-mutation may be either by immunohistochemistry (IHC) or next-generation sequencing (NGS) as per routine clinical care.

Cohort B: histological diagnosis of IDH-wildtype astrocytoma, WHO grade II-IV. IDH-wildtype status or absence of IDH-mutation may be either by IHC or NGS as per routine clinical care. The IDH-wildtype patients should have >80% probability to be alive in 6 months, and the online nomogram calculator below may be used to estimate the 6-month probability: http://cancer4.case.edu/rCalculator/rCalculator.html (Gittleman et al., 2016). The ideal patients are favorable IDH-wildtype astrocytoma patients who are expected to have prolonged survival, such as age ≤ 40 or grade 2-3 tumors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy Planning

MRI and RS-fMRI sequences are performed for radiation therapy planning

Prior to radiation therapy

1 visit (in-person)

Radiation Therapy

Participants undergo standard of care radiation therapy

6-8 weeks

Follow-up

Participants are monitored for neurocognitive changes and quality of life at multiple intervals

10 years

Visits at 6 months, 2 years, 5 years, and 10 years post-therapy

What Are the Treatments Tested in This Trial?

Interventions

• NIH Toolbox Cognitive Battery
• Radiation Therapy
• RS-fMRI

How Is the Trial Designed?

Group I: IDH-wildtype astrocytoma Experimental Treatment 1 Intervention

After enrollment and before beginning standard of care radiation therapy (RT), MRI will be obtained for RT planning as per standard of care (SOC), and the RS-fMRI sequences will be performed at the same time. At approximately 6 months, 2 years, 5 years, and 10 years from the completion of RT, RS-fMRIs will be performed.

Group II: IDH-mutant astrocytoma or oligodendroglioma Experimental Treatment 1 Intervention

After enrollment and before beginning standard of care radiation therapy (RT), MRI will be obtained for RT planning as per standard of care (SOC), and the RS-fMRI sequences will be performed at the same time. At approximately 6 months, 2 years, 5 years, and 10 years from the completion of RT, RS-fMRIs will be performed.

Group III: Benign Brain Tumor Experimental Treatment 1 Intervention

After enrollment and before beginning standard of care radiation therapy (RT), MRI will be obtained for RT planning as per standard of care (SOC), and the RS-fMRI sequences will be performed at the same time. At approximately 6 months, 2 years, 5 years, and 10 years from the completion of RT, RS-fMRIs will be performed.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in United States as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

The Foundation for Barnes-Jewish Hospital

Collaborator

Trials

43

Recruited

6,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12326604/

Proton therapy for adult type IDH-mutated glioma Gliomas with isocitrate dehydrogenase (IDH) mutation affect young adults with a long-life expectancy. While radiotherapy is effective, studies ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03180502

Study Details | NCT03180502 | Proton Beam or Intensity- ... Intensity-modulated or photon beam radiation therapy uses high-energy x-ray beams shaped to treat the tumor and may also cause less damage to normal tissue. It ...

3. practicalradonc.org practicalradonc.org/article/S1879-8500(22)00144-8/fulltext

Radiation Therapy for IDH-Mutant Grade 2 and Grade 3 ... This guideline aims to guide practitioners on the best management of patients with IDH-mutant grade 2 and grade 3 diffuse glioma, including ...

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000213797

Characteristics and Outcomes of Patients With IDH-Mutant ... Patients with G2 and G3 IDH-mutant (IDHm)-gliomas are responsive to chemotherapy and have median overall survival (OS) that exceeds a decade, ...

5. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-025-02702-y

Proton therapy for adult type IDH-mutated glioma: Proglio-1, a ... Gliomas with isocitrate dehydrogenase (IDH) mutation affect young adults with a long-life expectancy. While radiotherapy is effective, studies ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10227167/

Analysis of safety and efficacy of proton radiotherapy for IDH ... While median survival in patients with IDH-mutated diffuse glioma is 6–10 + years, median survival in patients with IDH wildtype diffuse glioma ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03180502

Study Details | NCT03180502 | Proton Beam or Intensity- ... This randomized phase II clinical trial studies the side effects and how well proton beam or intensity-modulated radiation therapy works in preserving brain ...

8. astro.org astro.org/news-and-publications/news-and-media-center/news-releases/2022/astro-issues-clinical-guideline-on-radiation-therapy-for-idh-mutant-glioma

ASTRO issues clinical guideline on radiation therapy ... A new clinical guideline from the American Society for Radiation Oncology (ASTRO) provides recommendations on the use of radiation therapy to treat patients ...