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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the repeatability of magnetic resonance imaging (MRI) in patients with isocitrate dehydrogenase 1 (IDH1) mutant (mIDH1) low-grade diffuse glioma \[World Health Organization (WHO) grade 2\] who are receiving off-label ivosidenib.

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 makes the drug Ivosidenib unique for treating low-grade glioma?

Ivosidenib is unique because it specifically targets mutations in the IDH1 gene, which are common in certain types of gliomas, potentially offering a more personalized treatment approach compared to traditional therapies that do not target specific genetic mutations. ^{1 2 3 4 5}

Research Team

Katherine Peters

Principal Investigator

Duke University

Eligibility Criteria

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

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

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

Exclusion Criteria

Inability to have MRIs

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

MRI as a central component of clinical trials analysis in brainstem glioma: a report from the Pediatric Brain Tumor Consortium (PBTC). [2021]

2. England pubmed.ncbi.nlm.nih.gov

Quantitative relaxometry using synthetic MRI could be better than T2-FLAIR mismatch sign for differentiation of IDH-mutant gliomas: a pilot study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

DCE and DSC MR perfusion imaging in the differentiation of recurrent tumour from treatment-related changes in patients with glioma. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Metabolic imaging of low-grade gliomas with three-dimensional magnetic resonance spectroscopy. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Inter-observer variability in the measurement of diffuse intrinsic pontine gliomas. [2021]