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

NCT ID: NCT05559853

Condition: Brain Metastases
Brain Metastases, Adult
Metastatic Brain Tumor
Metastatic Brain Cancer

Conditions: Official terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms

Conditions: 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

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: CEST-MRF
Description: 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.
Arm group label: Healthy participants
Arm group label: Participants with Brain Metastases

Other name: chemical exchange saturation transfer magnetic resonance fingerprinting method

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).

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
Criteria:
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 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) and patients (SA1 & 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Address:
City: New York
Zip: 10065
Country: United States

Status: Recruiting

Contact:
Last name: Ouri Coheb, PhD

Phone: 646-608-8259
Email: coheno1@mskcc.org

Start date: September 22, 2022

Completion date: September 22, 2027

Lead sponsor:
Agency: Memorial Sloan Kettering Cancer Center
Agency class: Other

Source: Memorial Sloan Kettering Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05559853
http://www.mskcc.org

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