Magnetic Resonance (MR) Imaging to Determine High Risk Areas in Patients With Malignant Gliomas and to Design Potential Radiation Plans and to Examine Metabolite Changes in Gliomas and Other Solid Tumors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

The researchers think that the use of advanced MR imaging may help people with this disease, because it may better predict areas within a malignant glioma (brain tumor) that are at a high risk of recurring. WeThe reserchers are doing this study to see whether this advanced imaging is a safe treatment that causes few or mild side effects in people with brain tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Suspected or Histopathologically proven diagnosis of high grade or low glioma or tumor is suspected to harbor an isocitrate dehydrogenase (IDH) mutation

May undergo radiation therapy

Patient and/or guardian is able to provide written informed consent prior to study registration

Age ≥ 18 years old

Disqualifiers

Extreme claustrophobia that precludes MRI scan

Known allergic reaction to Gd-DTPA

Any contraindication to gadolinium intravenous contrast as per standard Department of Radiology contrast guidelines

Any absolute contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander).

Trial design

Design model

Single group

Treatments tested in this trial

  • MRI and advanced MRI sequences

    Procedure/Surgery

    This is a nonrandomized study in which each patient will receive the standard clinical care (in the form of surgery, radiation therapy and/or chemotherapy), as per the treating physician. Surgical resection will be performed at the discretion of the treating Neurooncologist and/or Neurooncology Tumor Board. Advanced brain MRIs with the 2 (or, in some cases, 3) special sequences will be obtained at the time of the clinically scheduled contrast MRIs, which are usually obtained immediately prior to and 1 months±3 weeks after radiation therapy if the patient requires radiation therapy for his/her tumor. The advanced brain MRI may also be obtained before surgery for suspected or confirmed gliomas, as per the standard of care, in some patients who may or may not require radiation therapy.

Treatment groups

135 Participants
are divided into 1 treatment group
Group A: MRIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To assess the utility of baseline advanced MRI & changes between baseline & follow up advanced MRI in predicting high risk areas that are likely to develop progressive glioma despite chemoradiotherapy.

Time frame
1 -7 weeks before radiation treatment, about two months after treatment, and about every two months thereafter for the duration of the study.

Secondary outcomes

1

To compare radiation therapy simulations in patients with gliomas using conventional and baseline advanced MRI data.

Time frame
prior to and 1 months±3 weeks after radiation therapy.
2

feasibility of 2HG spectroscopy

Time frame
2 years

Other outcomes

Sponsors and contacts

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