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Brain MRF for Acute Leukemia
N/A
Waitlist Available
Led By Mari Dallas, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age range: 0 - 30 years
Meets diagnostic criteria for acute leukemia including acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML) and myeloproliferative neoplasm/leukemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and during chemotherapy(up to 3.5 years)
Awards & highlights
Summary
This trial aims to use a brain imaging tool called Magnetic Resonance Fingerprinting (MRF) to study brain changes in young patients with acute leukemia who are receiving chemotherapy. The study will also
Who is the study for?
This trial is for children, adolescents, and young adults with acute leukemia. Participants must be diagnosed with conditions like Acute Lymphoblastic Leukemia or Myeloproliferative Neoplasms. Specific eligibility criteria are not provided but typically include factors like age range, health status, and type of leukemia.
What is being tested?
The study tests the use of Magnetic Resonance Fingerprinting (MRF) to detect changes in brain matter due to chemotherapy in acute leukemia patients. It also includes electronic cognitive function tests on iPads to assess memory and brain function during treatment.
What are the potential side effects?
While MRF itself does not have side effects as it's a non-invasive imaging technique, the focus is on identifying potential neurocognitive side effects from chemotherapy drugs used in treating acute leukemia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 30 years old or younger.
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I have been diagnosed with acute leukemia, such as ALL, AML, or a related condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and during chemotherapy(up to 3.5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and during chemotherapy(up to 3.5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of alterations in brain structure as measured by mean myelin water fraction
Secondary outcome measures
Incidence of change in tissue evaluation using brain property mapping
Other outcome measures
Incidence of brain tissue changes using neurocognitive testing
Trial Design
1Treatment groups
Experimental Treatment
Group I: MRF +/-Neurocognitive TestingExperimental Treatment1 Intervention
Once the participants meeting the inclusion criteria are identified and formally consent to participate in the study, each participant will undergo a baseline MRF imaging exam along with the neurocognative testing, preferably prior to starting induction chemotherapy. The total treatment duration for an individual participant can vary anywhere between 6 months - 3 years depending on the type of acute leukemia, so investigator plans to obtain MRF scans every 6 months during the therapy as well as during the first year of the off -therapy period
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Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
459 Previous Clinical Trials
32,268 Total Patients Enrolled
Mari Dallas, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Rainbow Babies & Children's Hospital, Case Comprehensive Cancer Center
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