~29 spots leftby Dec 2025

MR Spectroscopy for Brain Tumor

Recruiting in Palo Alto (17 mi)
JW
Overseen byJing Wu, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: National Cancer Institute (NCI)
Disqualifiers: Pregnancy, Hypertension, Heart failure, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Background: Glioma is a type of brain cancer. Some of these tumors have gene mutations. These mutations can cause a substance called 2-HG to build up in the brain. This makes the tumors more aggressive. Researchers want to better understand 2-HG buildup in the brain. They hope this can help them design better ways to test for gliomas. Objective: To monitor the level of 2-HG in the brains of people with gliomas that have mutations in the IDH1 or IDH2 genes. Eligibility: People ages 18 and older with gliomas with mutations in the IDH1 or IDH2 genes Design: Participants will be screened with: Medical and cancer history Physical exam Reviews of their symptoms and ability to perform normal activities Blood and urine tests MRI scan Samples of their tumor from a past surgery Documentation of their diagnosis and mutation status Participants will have an initial evaluation. This will include repeats of screening tests. It will also include: Neurological exam MRS and MRI scans of the brain: Participants will lie on a table that slides into a metal cylinder. A coil or soft padding will be placed around their head. They will have a contrast agent injected into a vein. Pictures will be taken of the brain. Participants will have follow-up visits every 2-6 month for the rest of their life. Visits will include scans. ...

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment MRS and MRI scans of the brain, AG-881, for brain tumors?

MR spectroscopy (MRS) can help in identifying active and microscopic disease in brain tumors, which MRI alone might miss, and it can also differentiate between tumor types and assess treatment outcomes. This suggests that MRS, as part of the treatment, could improve the accuracy of diagnosing and monitoring brain tumors.12345

Is MR Spectroscopy safe for humans?

MR Spectroscopy (MRS) is generally considered safe as it is a non-invasive imaging technique similar to MRI (magnetic resonance imaging), which has been widely used in clinical settings for various conditions without significant safety concerns.16789

How does MR Spectroscopy differ from other treatments for brain tumors?

MR Spectroscopy is unique because it is a non-invasive imaging technique that analyzes the chemical composition of brain tumors, helping to distinguish between different types and grades of tumors. Unlike traditional treatments that focus on removing or shrinking tumors, MR Spectroscopy provides detailed metabolic information that can guide diagnosis and treatment planning.310111213

Research Team

JW

Jing Wu, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

This trial is for adults with gliomas (a type of brain cancer) that have specific mutations called IDH1 or IDH2. Participants must be over 18, able to perform daily activities at a reasonable level, and have normal kidney function. Pregnant women and individuals with conditions that could affect the study are excluded.

Inclusion Criteria

My kidney function is normal, based on creatinine levels or clearance.
I can care for myself but may need occasional help.
My glioma has an IDH1 or IDH2 mutation confirmed by a DNA test.
See 4 more

Exclusion Criteria

Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results (such as allergy to gadolinium contrast, metal implants and so on).
I am not pregnant and can stop breastfeeding for 72 hours for an MRI scan.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Initial Evaluation

Participants undergo neurological exam, MRS and MRI scans of the brain, and repeat screening tests

1-2 weeks
1 visit (in-person)

Longitudinal Monitoring

Participants have follow-up visits every 2-6 months for the rest of their life, including scans to monitor 2-HG levels

Ongoing
1 visit every 2-6 months (in-person)

Follow-up

Participants are monitored for safety and effectiveness after initial evaluation and during ongoing monitoring

5 years

Treatment Details

Interventions

  • MRS and MRI scans of the brain (MR Spectroscopy)
Trial OverviewThe study uses advanced MRI scans to monitor levels of a substance called 2-HG in the brains of patients with these gene mutations. The goal is to understand how this buildup relates to tumor aggressiveness and help design better diagnostic tests.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: 3/Arms 3Experimental Treatment2 Interventions
Monitoring of quantitative levels of 2-hydroxyglutarate (2-HG) via proton magnetic resonance spectroscopy (1H-MRS)
Group II: 2/Arm 2Experimental Treatment1 Intervention
Monitoring of quantitative levels of 2-hydroxyglutarate (2-HG) via proton magnetic resonance spectroscopy (1H-MRS) and HP 13C pyruvate MRSI
Group III: 1/Arm 1Experimental Treatment1 Intervention
Monitoring of quantitative levels of 2-hydroxyglutarate (2-HG) via proton magnetic resonance spectroscopy (1H-MRS) -- THIS ARM IS NOW CLOSED

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
National Institutes of Health Clinical CenterBethesda, MD
Loading ...

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14080
Patients Recruited
41,180,000+

Findings from Research

MR-spectroscopy guided target delineation for high-grade gliomas.Pirzkall, A., McKnight, TR., Graves, EE., et al.[2019]
[Usefulness of Cho/Cr ratio in proton MR spectroscopy for differentiating residual/recurrent glioma from non-neoplastic lesions].Ando, K., Ishikura, R., Nagami, Y., et al.[2022]
Intracranial tumors in children: small single-voxel proton MR spectroscopy using short- and long-echo sequences.Tzika, AA., Vigneron, DB., Dunn, RS., et al.[2019]
Proton MR spectroscopy of intracranial tumours: in vivo and in vitro studies.Gill, SS., Thomas, DG., Van Bruggen, N., et al.[2019]
1H-MRS in vivo predicts the early treatment outcome of postoperative radiotherapy for malignant gliomas.Tarnawski, R., Sokol, M., Pieniazek, P., et al.[2019]
Changes in serial magnetic resonance spectroscopy predict outcome in high-grade glioma during and after postoperative radiotherapy.Quon, H., Brunet, B., Alexander, A., et al.[2011]
Evaluating Magnetic Resonance Spectroscopy as a Tool for Monitoring Therapeutic Response of Whole Brain Radiotherapy in a Mouse Model for Breast-to-Brain Metastasis.Chae, WH., Niesel, K., Schulz, M., et al.[2020]
Phase II trial of radiosurgery to magnetic resonance spectroscopy-defined high-risk tumor volumes in patients with glioblastoma multiforme.Einstein, DB., Wessels, B., Bangert, B., et al.[2022]
In vivo 3-T MR spectroscopy in the distinction of recurrent glioma versus radiation effects: initial experience.Rabinov, JD., Lee, PL., Barker, FG., et al.[2022]
Magnetic resonance spectroscopy in intracranial tumours of glial origin.Jaskólski, DJ., Fortuniak, J., Majos, A., et al.[2019]
Non-invasive in vivo localized 1H spectroscopy of human astrocytoma implanted in rat brain: regional differences followed in time.van Vaals, JJ., Bergman, AH., van den Boogert, HJ., et al.[2019]
In vivo 1H NMR spectroscopy of an intracerebral glioma in the rat.Remy, C., Von Kienlin, M., Lotito, S., et al.[2019]
Spatially localized in vivo 1H magnetic resonance spectroscopy of an intracerebral rat glioma.Ross, BD., Merkle, H., Hendrich, K., et al.[2019]

References

MR-spectroscopy guided target delineation for high-grade gliomas. [2019]
[Usefulness of Cho/Cr ratio in proton MR spectroscopy for differentiating residual/recurrent glioma from non-neoplastic lesions]. [2022]
Intracranial tumors in children: small single-voxel proton MR spectroscopy using short- and long-echo sequences. [2019]
Proton MR spectroscopy of intracranial tumours: in vivo and in vitro studies. [2019]
1H-MRS in vivo predicts the early treatment outcome of postoperative radiotherapy for malignant gliomas. [2019]
Changes in serial magnetic resonance spectroscopy predict outcome in high-grade glioma during and after postoperative radiotherapy. [2011]
Evaluating Magnetic Resonance Spectroscopy as a Tool for Monitoring Therapeutic Response of Whole Brain Radiotherapy in a Mouse Model for Breast-to-Brain Metastasis. [2020]
Phase II trial of radiosurgery to magnetic resonance spectroscopy-defined high-risk tumor volumes in patients with glioblastoma multiforme. [2022]
In vivo 3-T MR spectroscopy in the distinction of recurrent glioma versus radiation effects: initial experience. [2022]
Magnetic resonance spectroscopy in intracranial tumours of glial origin. [2019]
Non-invasive in vivo localized 1H spectroscopy of human astrocytoma implanted in rat brain: regional differences followed in time. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
In vivo 1H NMR spectroscopy of an intracerebral glioma in the rat. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Spatially localized in vivo 1H magnetic resonance spectroscopy of an intracerebral rat glioma. [2019]