Recruiting

Observational Study

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT06421155

Conditions

Acute Leukemia

Acute Lymphoblastic Leukemia, Pediatric

Acute Myeloid Leukemia in Children

Myeloproliferative Neoplasm

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Interventions

MRF with neurocognative studies

Study Details

Brief summary:

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

Acute Leukemia

Acute Lymphoblastic Leukemia, Pediatric

Acute Myeloid Leukemia in Children

Myeloproliferative Neoplasm

Study ID

NCT06421155

Start date

Oct 4, 2024

Status verified date

Oct, 2026

Completion date

Jun 14, 2028

Anticipated

Primary completion date

Jun 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: MRF +/-Neurocognitive Testing

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

Interventions

MRF with neurocognative studies

Magnetic Resonance Imaging is used to assess the risk of neurocognitive side effects in pediatric and AYA patients with acute leukemia receiving chemotherapy and participants will also be asked to complete a neurocognitive battery designed by Cogstate and administered on iPad in a simple gaming format

Primary outcome measure

  • Incidence of alterations in brain structure as measured by mean myelin water fraction [ Time Frame: Baseline and during chemotherapy(up to 3.5 years) ]

Central Contacts and Locations

Central contacts

Anupam Verma, MD

216-844-1404Anupam.verma@uhhospitals.org

Locations

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

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Anupam Verma, MD

216-844-1404Anupam.verma@uhhospitals.org

Principal Investigator:

Anupam Verma, MD

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Keywords

  • Acute Leukemia Children
  • Acute Leukemia Adolescents
  • Acute Leukemia Young Adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.