Brain MRF in Children, Adolescents and Young Adults With Acute Leukemia

NCT06421155 | Suspended DMC

• 1 other identifier: CASE3923
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 Myeloid Leukemia in Children; Myeloproliferative Neoplasm; Acute Lymphoblastic Leukemia, Pediatric

Keywords

Acute Leukemia Children; Acute Leukemia Adolescents; Acute Leukemia Young Adults

Outcome Measures

Primary Outcomes (1)

• Incidence of alterations in brain structure as measured by mean myelin water fraction

  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.

  Baseline and during chemotherapy(up to 3.5 years)

Secondary Outcomes (1)

• Incidence of change in tissue evaluation using brain property mapping

  Baseline, every 6 months during the duration of therapy(up to 3.5 years), and every 6 months during the first year of the off-therapy period.

Other Outcomes (1)

• Incidence of brain tissue changes using neurocognitive testing

  Baseline, every 6 months during the duration of therapy(up to 3.5 years), and every 6 months during the first year of the off-therapy period.

Study Arms (1)

MRF +/-Neurocognitive Testing

OTHER

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

Other: MRF with neurocognative studies

Interventions

MRF with neurocognative studies OTHER

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

MRF +/-Neurocognitive Testing

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

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

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases

Study Officials

• Mari Dallas, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 20, 2024
• Study Start: October 4, 2024
• Primary Completion (Estimated): June 14, 2027
• Study Completion (Estimated): June 14, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be provided within 12 months from study completion and for at least 6 years after study closure.
• Access Criteria: Study team will only have access to submit data

Locations

US (1)