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

Jonsson Comprehensive Cancer Center

Status: Enrolling

Conditions: Malignant Brain Neoplasm; Metastatic Malignant Neoplasm in the Brain

Treatments: Procedure: Advanced Magnetic Resonance Imaging; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07339085

25-1250 (Other Identifier)

NCI-2025-06605 (Registry Identifier)

P30CA016042 (U.S. NIH Grant/Contract)

R21CA303383 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Patients with contraindications to MRI, severe renal impairment
• Patients with evidence of disseminated leptomeningeal disease

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Aim 1 (advanced MRI)

Experimental group

Description:

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.

Treatment:

Procedure: Biospecimen Collection

Procedure: Magnetic Resonance Imaging

Procedure: Advanced Magnetic Resonance Imaging

Aim 2 (advanced MRI)

Experimental group

Description:

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.

Treatment:

Procedure: Magnetic Resonance Imaging

Procedure: Advanced Magnetic Resonance Imaging