Clinical trial · Interventional
Brain MRF in Children, Adolescents and Young Adults With Acute Leukemia
A Pilot Study of Brain Magnetic Resonance Fingerprinting in Children, Adolescents and Young Adults With Acute Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Why stopped (as posted): Voluntary hold by PI
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Acute Lymphoblastic Leukemia, Pediatric | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Acute Myeloid Leukemia in Children | Acute Lymphoblastic Leukemia | PROBABILISTIC | 0.70 |
| Myeloproliferative Neoplasm | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRF with neurocognative studies | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- MRF +/-Neurocognitive Testing
- description
- 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
- interventionNames
- Other: MRF with neurocognative studies
Primary outcomes (1)
- measure
- Incidence of alterations in brain structure as measured by mean myelin water fraction
- timeFrame
- Baseline and during chemotherapy(up to 3.5 years)
- description
- Mean myelin water fraction is measured by Student's T-test. The two-tailed means comparison will be considered statistically significant if a p-value of less than 0.5 is observed.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Age range: 0 - 30 years * Participants from University Hospitals Rainbow Babies \& Children's Hospital, UH Seidman Cancer Center, and participants referred from outside facilities diagnosed with acute leukemia. * Meets diagnostic criteria for acute leukemia including acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML) and myeloproliferative neoplasm/leukemia. * Participants must have the ability to understand and the willingness to sign a written informed consent document. Participants who are 14 years and older must have the ability to understand and the willingness to sign a written informed consent document. Participants who are between the ages of 7 to 13 will be given an information sheet that explains the study to them. The information sheet may be used for study participants between the ages of 14-17 if it would better inform the child about the nature and procedures that will undergo as a participant in the study. Exclusion Criteria: * Individuals that are \>2 weeks into the induction chemotherapy for acute leukemia. * 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
References
Publications (0)
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