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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Brain Metastases; Metastatic Brain Tumor; Brain Metastases, Adult; Metastatic Brain Cancer
• Intervention / Treatment: Diagnostic test: CEST-MRF

• Study Type: Observational
• Enrollment (Estimated): 94

Contacts and Locations

• Study Contact: Name: Ouri Cohen, PhD; Phone Number: 646-608-8259; Email: coheno1@mskcc.org
• Study Contact Backup: Name: Nelson Moss, MD; Phone Number: 212-639-7075; Email: mossn@mskcc.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Contact: Ouri Coheb, PhD; Phone Number: 646-608-8259

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study investigators will discuss participant potentially eligible for research participation within their interdisciplinary brain metastasis disease management team. These potential participants will then be contacted by their treating physician or investigator team. Study investigators will prioritize consenting participants who are planned to undergo SRS and, when possible, will attempt to coordinate the research scan with their clinically necessary MRI scans to minimize time and disruption for the participant.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Ouri Cohen, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2022
• Primary Completion (Estimated): September 22, 2027
• Study Completion (Estimated): September 22, 2027

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: MRI; Healthy Volunteers; Memorial Sloan Kettering Cancer Center; Brain Metastases; metastatic brain tumor; metastatic brain cancer; Brain Metastases, Adult; untreated brain metastasis; CEST-MRF; chemical exchange saturation transfer magnetic resonance fingerprinting; 22-191
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms; Neoplasms, Second Primary
• Other Study ID Numbers: 22-191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes