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Recruiting NCT05559853

Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment

Observational Brain Metastases Brain Metastases, Adult Metastatic Brain Tumor Metastatic Brain Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CEST-MRF.
Who it may be relevant to
Registry conditions: Brain Metastases, Brain Metastases, Adult, Metastatic Brain Tumor, Metastatic Brain Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Development of a Clinical CEST MR Fingerprinting Method for Treatment Response Assessment in Brain Metastases

Overview

The purpose of this study is to develop and test a new magnetic resonance imaging (MRI) technique to see if it can be used to tell the difference between tumor growth from worsening of cancer and growth from the effects of treatment in participants who have brain tumors treated with radiation therapy called stereotactic radiosurgery (SRS).

Interventions

  • Diagnostic test CEST-MRF
    CEST-MRF enables accurate quantification of both proton exchange rates and volume fractions in a fraction of the time required by conventional pulse sequences will be developed and optimized.

Primary outcome measures

  • Change of Rapid chemical exchange saturation transfer (CEST) imaging with magnetic resonance fingerprinting (MRF)/CEST-MRF parameters with and without motion [Time frame: Up to 3 years]
Secondary outcome measures (2)
  • Create CEST-MRF parameter maps [Time frame: Up to 3 years]
  • Measure longitudinal changes in CEST-MRF after SRS [Time frame: Up to 3 years]

Eligibility criteria

Inclusion criteria

Healthy volunteers \[for Study Aim 1 (SA1) and Study Aim 2 (SA2)\] will be entered into the study if they meet the following criteria:

  • Age ≥ 18 years
  • Able to understand and give informed consent
  • No known cancer diagnosis

Patients \[for Study Aim 1 (SA1)\] will be entered into the study if they meet the following criteria:

  • Age ≥ 18 years
  • Able to understand and give informed consent
  • At least one untreated brain metastasis > 1cm (e.g., an enhancing lesion in the brain of a patient with known systemic cancer determined likely to represent metastasis by neuroradiologist)

Patients \[for Study Aim 3 (SA3)\] will be entered into the study if they meet the following criteria:

  • Age ≥ 18 years
  • Able to understand and give informed consent
  • At least one untreated brain metastasis > 1cm (e.g., an enhancing lesion in the brain of a patient with known systemic cancer determined likely to represent metastasis by neuroradiologist)
  • Planned SRS treatment

Exclusion criteria

Healthy volunteers (SA1 \& SA2) and patients (SA1 \& SA3) exclusion criteria:

  • Pregnant or breastfeeding women
  • Pre-existing medical conditions, including the likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
  • Age < 18 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York

Identifiers

NCT: NCT05559853 · 22-191

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗