Advanced Magnetic Resonance Imaging for the Identification of Recurrent Brain Tumors and Radiation Necrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-28

Study Completion Date

2030-07-30

Brief Summary

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This clinical trial studies whether advanced magnetic resonance imaging (MRI) techniques, including diffusion-relaxation correlation spectrum imaging (DR-CSI) and sodium imaging, can be used to identify the difference between brain tumors that come back after a period of improvement (recurrent) and treatment-related tissue damage (radiation necrosis \[RN\]). Radiation therapy is often used in the treatment of brain tumors. Radiation treatment response can be difficult to assess and is usually done using conventional MRI, which uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. Current imaging techniques have a limited ability to identify the difference between recurrent brain tumor and RN due to their similar appearance on conventional MRI and overlapping clinical presentation. This makes it hard for doctors to plan the best way to treat these tumors. DR-CSI is a new MRI technique with the potential to detect microscopic tissue components with different characteristics. Sodium imaging is an MRI technique that estimates the total sodium concentration in the obtained images. It may be able to identify the small structures within the tissue of brain tumors. Advanced MRI techniques like DR-CSI and sodium imaging may be effective in identifying the difference between recurrent brain tumors and RN.

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Detailed Description

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PRIMARY OBJECTIVES:

I. Develop and validate dual-nuclei microstructural MRI biomarkers to differentiate between recurrent brain metastasis (rBM) and RN.

II. Investigate longitudinal microstructural changes following stereotactic radiosurgery (SRS) treatment and predict clinical outcome.

OUTLINE: Patients are assigned to 1 of 2 aims.

AIM 1: Patients undergo advanced DR-CSI and sodium MRI over 30 minutes prior to standard of care (SOC) surgical resection or biopsy. Patients also undergo clinical MRI and tissue sample collection on study.

AIM 2: Patients undergo advanced DR-CSI and sodium MRI over 30 minutes before SRS and 2 weeks, 3 months, and 6 months post-SRS. Patients also undergo clinical MRI on study.

Conditions

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Malignant Brain Neoplasm Metastatic Malignant Neoplasm in the Brain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Aim 1 (advanced MRI)

Patients undergo advanced DR-CSI and sodium MRI over 30 minutes prior to SOC surgical resection or biopsy. Patients also undergo clinical MRI and tissue sample collection on study.

Group Type EXPERIMENTAL

Advanced Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo advanced DR-CSI and sodium MRI

Biospecimen Collection

Intervention Type PROCEDURE

Undergo tissue sample collection

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo clinical MRI

Aim 2 (advanced MRI)

Patients undergo advanced DR-CSI and sodium MRI over 30 minutes before SRS and 2 weeks, 3 months, and 6 months post-SRS. Patients also undergo clinical MRI on study.

Group Type EXPERIMENTAL

Advanced Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo advanced DR-CSI and sodium MRI

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo clinical MRI

Interventions

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Advanced Magnetic Resonance Imaging

Undergo advanced DR-CSI and sodium MRI

Intervention Type PROCEDURE

Biospecimen Collection

Undergo tissue sample collection

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo clinical MRI

Intervention Type PROCEDURE

Other Intervention Names

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AMRI Biological Sample Collection Biospecimen Collected Specimen Collection Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years old
* Diagnosed with metastatic brain tumor
* AIM 1: Scheduled for surgical resection or tissue biopsy +/- laser interstitial thermal therapy (LITT)
* AIM 2: Scheduled for SRS treatment