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

Recruiting

• Conditions: Metastatic Brain Tumor; Brain Metastases; Brain Metastases, Adult; Metastatic Brain Cancer
• Interventions: Diagnostic Test: CEST-MRF

• Registration Number: NCT05559853
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-22
• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2027-09-22
• Study Completion: 2027-09-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 119

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy participants	CEST-MRF	Participants will have no known cancer diagnosis. Volunteers enrolled on this protocol may undergo multiple MRI examinations periodically for studies of reproducibility.
Participants with Brain Metastases	CEST-MRF	Participants will have at least one untreated brain metastasis \> 1cm

Primary Outcome Measures

Name	Time	Method
Change of Rapid chemical exchange saturation transfer (CEST) imaging with magnetic resonance fingerprinting (MRF)/CEST-MRF parameters with and without motion	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 Outcome Measures

Name	Time	Method
Create CEST-MRF parameter maps	Up to 3 years	Develop an MRI physics-guided artificial intelligence approach to improve acquisition and reconstruction of multiparametric data
Measure longitudinal changes in CEST-MRF after SRS	Up to 3 years	Evaluate CEST-MRF changes before and after radiation therapy to assess potential role as predictive imaging biomarker for brain metastases

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States