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

StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Notable Recruitment resumed after suspension
    • Site details revised
  2. Minor Eligibility criteria expanded, about 6 words
    • Study description revised
    • Site details revised
  3. 2 versions Re-verified since Jun 4, 2026, no change to tracked fieldsv8-v9
  4. Stopped Trial status: Recruiting to Suspended Sponsor's reason: Voluntary hold by PI
    • Site details revised
    v7
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2025 to Oct 4, 2024
    • Site details revised
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Start date: Jan 1, 2025 to Apr 1, 2025v5
  2. Re-verified, no change to tracked fieldsv4
  3. Notable Start date: Jul 31, 2024 to Jan 1, 2025
    • Primary completion date: Nov 14, 2027 to Jun 14, 2027
    • Study completion date: Nov 14, 2028 to Jun 14, 2028
    v3
  4. Notable Start date: Jun 1, 2024 to Jul 31, 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06421155
Lead Sponsor Case Comprehensive Cancer Center
Conditions
(from sponsor)
Acute Leukemia, Acute Lymphoblastic Leukemia, Pediatric, Acute Myeloid Leukemia in Children, Myeloproliferative Neoplasm
Related terms Myeloproliferative Disorders, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov