NCT05559853

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Sep 2022Sep 2027

First Submitted

Initial submission to the registry

September 22, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 22, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2027

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

September 22, 2022

Last Update Submit

March 4, 2026

Conditions

Brain MetastasesBrain Metastases, AdultMetastatic Brain TumorMetastatic Brain Cancer

Keywords

Brain MetastasesHealthy Volunteersmetastatic brain tumormetastatic brain cancerBrain Metastases, AdultMRIuntreated brain metastasisCEST-MRFchemical exchange saturation transfer magnetic resonance fingerprinting22-191Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Create CEST-MRF parameter maps

    Up to 3 years

  • Measure longitudinal changes in CEST-MRF after SRS

    Up to 3 years

Study Arms (2)

Participants with Brain Metastases

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

Diagnostic Test: CEST-MRF

Healthy participants

Participants will have no known cancer diagnosis. Volunteers enrolled on this protocol may undergo multiple MRI examinations periodically for studies of reproducibility.

Diagnostic Test: CEST-MRF

Interventions

CEST-MRFDIAGNOSTIC_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.

Also known as: chemical exchange saturation transfer magnetic resonance fingerprinting method
Healthy participantsParticipants with Brain Metastases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ouri Cohen, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ouri Cohen, PhD

CONTACT

646-608-8259coheno1@mskcc.org

Nelson Moss, MD

CONTACT

212-639-7075mossn@mskcc.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2022

First Posted

September 29, 2022

Study Start

September 22, 2022

Primary Completion (Estimated)

September 22, 2027

Study Completion (Estimated)

September 22, 2027

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)