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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new brain imaging tool, Magnetic Resonance Fingerprinting (MRF), to detect brain changes in young people with acute leukemia undergoing chemotherapy. The goal is to identify early signs of brain function issues, a known side effect of the treatment, using quick, non-invasive scans. Participants will also engage in enjoyable, game-like memory and brain function tests on tablets. Young people with acute leukemia who have not yet started chemotherapy and are patients at specific hospitals are ideal candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment experiences.

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.

What prior data suggests that this brain imaging technique is safe for children, adolescents, and young adults with acute leukemia?

Research has shown that Magnetic Resonance Fingerprinting (MRF) provides a safe and non-invasive method for capturing brain images. It functions like a supercharged MRI, delivering detailed images quickly. Studies have found that MRF helps doctors detect brain changes without harmful side effects. Participants who underwent MRF scans reported no serious problems.

The brain tests in this study are also safe. Designed as fun games on tablets, they are easy and engaging, especially for kids. These short tests assess brain function without any known risks.

Overall, both the MRF scans and the brain tests are well-tolerated and safe for participants. Previous studies have not shown any evidence to suggest otherwise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MRF treatment for acute leukemia because it offers a unique way to monitor the brain’s health during and after chemotherapy. Unlike standard treatments that mainly focus on targeting leukemia cells, MRF combines advanced imaging with neurocognitive testing to track potential changes in brain function. This approach could help doctors catch and manage cognitive side effects much earlier, potentially improving the quality of life for patients undergoing intense cancer treatment.

What evidence suggests that MRF with neurocognitive studies is effective for monitoring brain changes in acute leukemia?

Research has shown that chemotherapy for acute leukemia can affect memory and brain function. Survivors may struggle with tasks like remembering locations and making decisions. This trial studies Magnetic Resonance Fingerprinting (MRF) as a method to detect these brain changes early. Participants will undergo MRF imaging exams, with some also receiving neurocognitive testing. The goal is to use MRF to identify individuals who might develop these side effects, potentially leading to better management and prevention strategies. Early results suggest that combining MRF with memory and thinking tests is manageable for patients and may effectively monitor brain health in leukemia patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Mari H Dallas, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/487895

Brain MRF in Children, Adolescents and Young Adults With ... The survival of children, adolescents and young adults (AYA) with acute leukemia has improved dramatically over the last two decades.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4425605/

Neurocognitive Outcomes in Long-term Survivors of ... There is evidence to suggest that ALL survivors treated with chemotherapy alone demonstrated signi cant differences in long-term neurocognitive function and ...

3. withpower.com withpower.com/trial/phase-leukemia-5-2024-1c52b

Brain MRF for Acute Leukemia ... MRF with neurocognitive studies will have tolerable side effects & efficacy for patients with Acute Lymphoblastic Leukemia, Myeloproliferative Disorder ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149763421003419

Effects of chemotherapy for acute lymphoblastic leukemia ... Studies demonstrate deficits across cognitive domains including spatial memory, executive function, short-term memory, anxiety and depression.

5. nature.com nature.com/articles/s41598-024-58128-1

Neuropsychological task outcomes among survivors of ... This study intended to explore the neuropsychological ramifications in childhood acute lymphoblastic leukemia (ALL) survivors in Malaysia ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5984038/

Magnetic Resonance Fingerprinting-An Overview - PMC MRF is a new approach to quantitative magnetic resonance imaging that allows simultaneous measurement of multiple tissue properties in a single, time-efficient ...

7. ejrnm.springeropen.com ejrnm.springeropen.com/articles/10.1186/s43055-020-00337-5

Role of magnetic resonance imaging in characterization of ... The study aims to characterize the MRI findings caused by the leukemic involvement of CNS structures and treatment-associated CNS complications

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8507535/

Current Applications and Future Development of Magnetic ... This review summarises recent studies detecting and characterising tumours using MRF, with a focus on brain tumours, prostate cancers, and abdominal/pelvic ...

9. karger.com karger.com/pne/article/54/5/310/277721/Magnetic-Resonance-Fingerprinting-to-Characterize

Magnetic Resonance Fingerprinting to Characterize ... In this study, we investigated MRF-derived T1 and T2 values in a heterogeneous sample of pediatric, adolescent, and young adult brain tumors to ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10330487/

Magnetic Resonance Fingerprinting: A Review of Clinical ... MRF is an approach to quantitative magnetic resonance imaging that allows for efficient simultaneous measurements of multiple tissue properties.