Brain MRF for Acute Leukemia

Overseen By Mari Dallas, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Heart pacemaker, Metal in body, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 6 months to 3 years

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The survival of children, adolescents and young adults (AYA) with acute leukemia has improved dramatically over the last two decades. This success is a result of using multiple chemotherapy drugs in combination, with the inclusion of drugs that enter the brain and prevent leukemia cells from growing there. Studies in these cancer survivors have shown that the exposure to these chemotherapy drugs can lead to risks for impaired brain function, also referred to as neurocognitive side effects of chemotherapy. There is an opportunity to identify participants at risk for these side effects and to prevent their development. The purpose of this study is to incorporate a brain imaging tool known as Magnetic Resonance Fingerprinting (MRF) to look for brain matter changes in acute leukemia participants receiving chemotherapy. The MRF scan will be performed at diagnosis and repeated at multiple times during the entire therapy duration as well as at defined intervals after therapy is complete. Investigators would also do an electronic test of memory and brain function (cognitive function), which would be administered in a gaming format on iPads or a similar device. The goal will be to correlate results of MRF imaging with the tests of cognitive function. The benefits of this imaging technique include that it can be done quickly (in minutes), it is non-invasive, it is resistant to motion-artifacts and it can be easily repeated for comparison purposes. The advantages of the cognitive test include its short duration of 20 minutes and its gaming format making it friendly for children to use.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is Brain MRF for Acute Leukemia safe for humans?

The safety data for treatments similar to Brain MRF, like chemotherapy for leukemia, show that there can be effects on the brain, such as changes in brain connectivity and cognitive functions. These effects have been observed in treatments for leukemia, but specific safety data for Brain MRF itself is not available. ^{1 2 3 4 5}

How is the Brain MRF treatment for acute leukemia different from other treatments?

The Brain MRF treatment for acute leukemia is unique because it focuses on neurocognitive studies, which means it looks at how the treatment affects brain function and thinking skills. This is different from other treatments that may not specifically address or monitor changes in brain function during and after treatment. ^{1 6 7 8 9}

Research Team

Mari H Dallas, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Rainbow Babies & Children's Hospital, Case Comprehensive Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with acute leukemia, such as ALL, AML, or a related condition.

Participants from University Hospitals Rainbow Babies & Children's Hospital, UH Seidman Cancer Center, and participants referred from outside facilities diagnosed with acute leukemia

I am 30 years old or younger.

Exclusion Criteria

I started my first leukemia treatment more than 2 weeks ago.

Individuals with either a heart pacemaker, heart defibrillator, metal in the eye, some types of metal elsewhere within the body such as certain surgical clips for aneurysms in the head, heart valve prostheses, electrodes, some other implanted devices, or any other MRI contraindication

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a baseline MRF imaging exam along with neurocognitive testing before starting induction chemotherapy

1 week

1 visit (in-person)

Treatment

Participants receive chemotherapy with MRF scans every 6 months during therapy

6 months to 3 years

Multiple visits (in-person) every 6 months

Follow-up

Participants are monitored for brain tissue changes and neurocognitive function every 6 months during the first year of the off-therapy period

1 year

2 visits (in-person)

Treatment Details

Interventions

• MRF with neurocognitive studies

Trial Overview 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.

Participant Groups

Group I: MRF +/-Neurocognitive Testing Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

References

1. China pubmed.ncbi.nlm.nih.gov

[Brain injury after induction chemotherapy in children with acute lymphoblastic leukemia]. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Prevalence of leukoencephalopathy in children treated for acute lymphoblastic leukemia with high-dose methotrexate. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

The relationship between cognitive and neuroimaging outcomes in children treated for acute lymphoblastic leukemia with chemotherapy only: A systematic review. [2018]

4. Italy pubmed.ncbi.nlm.nih.gov

The usefulness of sLORETA in evaluating the effect of high-dose ARA-C on brain connectivity in patients with acute myeloid leukemia: an exploratory study. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Structural and Functional Brain Imaging in Long-Term Survivors of Childhood Acute Lymphoblastic Leukemia Treated With Chemotherapy: A Systematic Review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

White matter and cerebral metabolite changes in children undergoing treatment for acute lymphoblastic leukemia: longitudinal study with MR imaging and 1H MR spectroscopy. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Childhood leukemia: central nervous system abnormalities during and after treatment. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

White versus gray matter function as seen on neuropsychological testing following bone marrow transplant for acute leukemia in childhood. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Brain damage after treatment for acute lymphoblastic leukemia. A report on 34 patients with special regard to MRI findings. [2019]