Clinical trial NCT05559853: Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment
Official title: Development of a Clinical CEST MR Fingerprinting Method for Treatment Response Assessment in Brain Metastases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Metastases
Brain Metastases, Adult
Metastatic Brain Tumor
Metastatic Brain Cancer
Keywords: Brain Metastases
Healthy Volunteers
metastatic brain tumor
metastatic brain cancer
Brain Metastases, Adult
MRI
untreated brain metastasis
CEST-MRF
chemical exchange saturation transfer magnetic resonance fingerprinting
22-191
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change of Rapid chemical exchange saturation transfer (CEST) imaging with magnetic resonance fingerprinting (MRF)/CEST-MRF parameters with and without motion
timeFrame: Up to 3 years
Secondary outcomes:
measure: Create CEST-MRF parameter maps
timeFrame: Up to 3 years
measure: Measure longitudinal changes in CEST-MRF after SRS
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Ouri Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
References: