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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05559853

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Brain Metastases Brain Metastases, Adult Metastatic Brain Tumor Metastatic Brain Cancer	Diagnostic Test: CEST-MRF

Study Design

Study Type:

Observational

Anticipated Enrollment :

94 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 22, 2022

Anticipated Primary Completion Date :

Sep 22, 2027

Anticipated Study Completion Date :

Sep 22, 2027

Arms and Interventions

Arm	Intervention/Treatment
Participants with Brain Metastases Participants will have at least one untreated brain metastasis > 1cm	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. Other Names: chemical exchange saturation transfer magnetic resonance fingerprinting method
Healthy participants Participants will have no known cancer diagnosis	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. Other Names: chemical exchange saturation transfer magnetic resonance fingerprinting method

Arm

Intervention/Treatment

Participants with Brain Metastases

Participants will have at least one untreated brain metastasis > 1cm

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.

Other Names:

chemical exchange saturation transfer magnetic resonance fingerprinting method

Healthy participants

Participants will have no known cancer diagnosis

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.

Other Names:

chemical exchange saturation transfer magnetic resonance fingerprinting method

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy volunteers [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
No known cancer diagnosis

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) and patients (SA2) exclusion criteria:

Any contraindication to MRI as defined by positive responses to the Safety Screen Questionnaire (Appendix A)
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