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

Brain Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05559853
• Other study ID #: 22-191
• Status: Recruiting
• Start date: September 22, 2022
• Est. completion date: September 22, 2027

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Ouri Cohen, PhD
• Phone: 646-608-8259
• Email: coheno1[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: September 22, 2027
• Est. primary completion date: September 22, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Metastases, Adult
• Brain Neoplasms
• Metastatic Brain Cancer
• Metastatic Brain Tumor
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Rapid chemical exchange saturation transfer (CEST) imaging with magnetic resonance fingerprinting (MRF)/CEST-MRF parameters with and without motion	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).	Up to 3 years

External Links

•   Memorial Sloan Kettering Cancer Center