MRI Scans for Low Grade Glioma

Overseen By Stevie Threatt

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: Ivosidenib

Disqualifiers: Inability to have MRIs

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the reliability of MRI scans for individuals with a specific brain tumor called IDH1 mutant low-grade glioma. The research focuses on patients already taking the drug ivosidenib (Tibsovo) and aims to determine if MRI results remain consistent over time for these patients. Candidates may be suitable if they have this type of glioma and are receiving treatment at the Duke Brain Tumor Center. As an unphased trial, this study provides a unique opportunity to contribute to understanding MRI reliability in this specific condition.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you are actively receiving ivosidenib.

What prior data suggests that MRI scans are safe for evaluating low-grade glioma?

Research has shown that ivosidenib is generally safe for patients with IDH1-mutant low-grade glioma, a type of brain tumor. In one study, some patients experienced serious side effects, but these were not life-threatening and were manageable. Typically, patients took a short break from the treatment rather than stopping it completely. Importantly, ivosidenib did not cause any major health issues that required hospitalization or urgent care. This suggests that ivosidenib is a safe option for patients with this condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how MRI scans can improve the understanding and treatment of low-grade gliomas. Unlike traditional imaging methods, this approach uses advanced MRI techniques like T1-pre, T2w, and volumetric 3D FLAIR sequences to provide a more detailed look at brain tumors. This could lead to better diagnosis and monitoring, potentially improving treatment decisions and outcomes for patients with low-grade gliomas.

What evidence suggests that MRI scans are effective for evaluating low-grade glioma?

Research shows that ivosidenib may help treat a specific type of brain tumor called IDH1-mutant low-grade glioma. Studies have found that 31% of patients responded well to treatment with ivosidenib. It significantly reduces tumor growth markers, with a 92.6% decrease in tumor 2-HG levels, which are linked to tumor development. Ivosidenib appears especially effective for nonenhancing tumors, which do not appear brightly on certain scans. Overall, ivosidenib could be a helpful option for people with this specific type of brain tumor.

Note: This trial focuses on the use of MRI scans for low-grade glioma and does not include ivosidenib as a treatment arm. ^{2 3 6 7 8}

Who Is on the Research Team?

Katherine Peters

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for patients with a type of brain tumor known as IDH1 mutant low-grade glioma. Participants should be receiving ivosidenib, an off-label treatment for this condition.

Inclusion Criteria

Written informed consent prior to beginning specific protocol procedures

Active patient treatment or evaluations at the Preston Robert Tisch Brain Tumor Center at Duke

My brain tumor is a low-grade glioma with an IDH1 mutation, and I am currently taking ivosidenib.

Exclusion Criteria

Inability to have MRIs

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

MRI Scan

Subjects undergo a routine Brain Tumor Imaging Protocol MRI scan with additional imaging sequences

1 day

1 visit (in-person)

Follow-up

Participants are monitored for repeatability of MRI imaging over a year

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Ivosidenib

Trial Overview The study focuses on the consistency of MRI scans in monitoring these specific brain tumors while patients are treated with ivosidenib. It aims to ensure that repeated MRIs give reliable results over time.

How Is the Trial Designed?

Group I: Magnetic Resonance Imaging (MRI) Scan Experimental Treatment 1 Intervention

Subjects will begin the MRI with T1-pre, T2w, and volumetric 3D Fluid Attenuated Inversion Recovery (FLAIR) images being obtained. The subject will be brought out of the MRI magnet and moved into a seated position and will then have a standard Brain Tumor Imaging Protocol MRI scan.

Ivosidenib is already approved in United States, European Union for the following indications:

Approved in United States as Tibsovo for:

• Acute myeloid leukemia (AML) with IDH1 mutation

Approved in European Union as Tibsovo for:

• Acute myeloid leukemia (AML) with IDH1 mutation

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Institut de Recherches Internationales Servier

Collaborator

Trials

91

Recruited

67,100+

Citations

1. servier.us servier.us/blog/agios-presents-new-pharmacodynamic-and-response-data-from-both-cohorts-of-the-perioperative-study-of-vorasidenib-and-tibsovo-ivosidenib-in-patients-with-idh1-mutant-positive-low-grade-glioma/

Agios Presents New Pharmacodynamic and Response ... Preliminary Efficacy Data Show 31% Overall Response Rate for Both Vorasidenib and TIBSOVO® with Postoperative Treatment –; – Vorasidenib and ...

2. investor.agios.com investor.agios.com/news-releases/news-release-details/agios-presents-new-pharmacodynamic-and-response-data-both

Press Release Details Preliminary Efficacy Data Show 31% Overall Response Rate for Both Vorasidenib and TIBSOVO® with Postoperative Treatment –.

3. nature.com nature.com/articles/s41591-022-02141-2

Vorasidenib and ivosidenib in IDH1-mutant low-grade glioma Tumor 2-HG concentrations were reduced by 92.6% (95% credible interval (CrI), 76.1–97.6) and 91.1% (95% CrI, 72.0–97.0) in patients treated with ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2304194

Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma In patients with grade 2 IDH-mutant glioma, vorasidenib significantly improved progression-free survival and delayed the time to the next intervention.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11795303/

Ivosidenib for the treatment of IDH1-mutant glioma, grades 2–4 Ivosidenib seems to be effective in both grade 2 and 3 nonenhancing tumors. Ivosidenib was less effective in patients with enhancing disease.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10313524/

Vorasidenib and ivosidenib in IDH1-mutant low-grade glioma The safety analysis set comprised randomized patients who received at least one dose of vorasidenib or ivosidenib either pre- or postoperatively ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2040

Retrospective study of ivosidenib for patients with recurrent ... Treatment with Ivosidenib therapy was associated with a manageable safety profile. In a subset of patients, there was disease stabilization in heavily pre- ...

8. ashp.org ashp.org/-/media/assets/products-services/AHFS/docs/Ivosidenib-for-Treatment-of-IDH-Mutant-Glioma_Off-Label-March-2024.pdf

Ivosidenib-for-Treatment-of-IDH-Mutant-Glioma_Off-Label- ... Grade 3 AEs resulted in treatment interruption, however, no serious AEs reported were attributable to study drugs, and no discontinuation ...