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NCT Number: NCT05559853

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

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).

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Key information

Conditions

Brain Metastases Brain Diseases Brain Metastases, Adult Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Metastatic Brain Cancer Metastatic Brain Tumor Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, 10065, United States

Location status: Recruiting

Location contact

Ouri Coheb, PhD

CONTACT

[email protected]

646-608-8259

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CEST-MRF

Diagnostic Test

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.

Other names: chemical exchange saturation transfer magnetic resonance fingerprinting method

Primary outcomes

  1. 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

    Develop a rapid and robust 3D CEST-MRF pulse sequence for clinical scanners using our preclinical CEST-MRF pulse sequence as a basis by evaluating the changes of the 6 CEST-MRF parameters with and without motion. These parameters include the water T1 and T2 relaxation (T1w,T2w), amide exchange rate (ksw) and volume fraction (fs) and the semi-solid exchange rate (kssw) and volume fraction (fss).

Secondary outcomes

  1. Create CEST-MRF parameter maps

    Time frame: Up to 3 years

    Develop an MRI physics-guided artificial intelligence approach to improve acquisition and reconstruction of multiparametric data

  2. Measure longitudinal changes in CEST-MRF after SRS

    Time frame: Up to 3 years

    Evaluate CEST-MRF changes before and after radiation therapy to assess potential role as predictive imaging biomarker for brain metastases

Study contacts

Contact information is provided by the study sponsor or research team.

Nelson Moss, MD

CONTACT

[email protected]

212-639-7075

Ouri Cohen, PhD

CONTACT

[email protected]

646-608-8259

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 29, 2022
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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