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

ConditionsMalignant Brain NeoplasmMetastatic Malignant Neoplasm in the Brain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonsson Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with contraindications to MRI, severe renal impairment

Patients with evidence of disseminated leptomeningeal disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Advanced Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo advanced DR-CSI and sodium MRI

  • Biospecimen Collection

    Procedure/Surgery

    Undergo tissue sample collection

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo clinical MRI

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Aim 1 (advanced MRI)Experimental treatment 3 interventions
Group B: Aim 2 (advanced MRI)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Imaging features of recurrent brain metastasis (rBM) and radiation necrosis (RN) (Aim 1)

Will compute the diffusion-relaxation (DR) spectra and total sodium concentration (TSC) within biopsy regions of interest and use Student t-test or Mann-Whitney U test, depending on the data distribution, to compare imaging features between rBM and RN groups. Specifically, for DR spectra, the test statistic at each spectral location will be used to identify spectral components associated viable tumor and treatment effect. The information will subsequently be used to partition the voxel-wise DR spectra and compute voxel-wise "viable tumor" and "treatment effect" fraction maps. Multivariate logistic regression models will assess the predictive value of the imaging biomarkers, including DR-correlation spectrum imaging (CSI) spectral components and TSC. Receiver operating characteristic (ROC) analysis will evaluate diagnostic performance, calculating area under the curve, sensitivity, specificity, and optimal cutoff values for differentiating rBM and RN.

Time frame
At time of advanced magnetic resonance imaging: Baseline
2

Stereotacic imaging-guided biopsies and correlation with tissue quantifications (Aim 1)

Will prospectively acquire DR-CSI and sodium imaging-guided biopsies of tumor tissue in regions with different imaging characteristics. Pearson or Spearman correlations will be computed between imaging features and quantitative histological measures of cellularity, extracellular fraction, and percentages of tumor and necrosis.

Time frame
Up to completion of surgery
3

Early imaging changes as predictors of clinical outcomes (Aim 2)

Will compute DR-CSI spectral components and TSC at each time point. Repeated measure analysis of variance will assess imaging changes over time. Will also plot trajectories of imaging biomarkers to visualize temporal patterns. Multivariate logistic regression models will evaluate early imaging changes (2 weeks and 3 months) as predictors of 6-month outcomes. Lesions will be stratified into responders (complete or partial response) and non-responders (stable disease or progression) based on their Response Assessment in Neuro-Oncology Brain Metastases assessment at 6-month post-SRS. ROC curves will assess the predictive performance of early microstructural imaging changes and the multivariate model. Primary tumor type will be included as a covariate in analyses.

Time frame
At baseline and 2 weeks, 3 months, and 6 months post-stereotactic radiosurgery (SRS)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jonsson Comprehensive Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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