18F-FLT (PET/CT) in Pediatrics With Myeloproliferative Neoplasms

Study Overview
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Brief Summary
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The Main purpose of this project to study the uptake pattern of FLT-PET and it is value in assessing the malignant hematopoiesis in MPN within the pediatric age group, in terms of diagnosis, staging and monitoring response to therapy. As well as, evaluating FLT-PET as a novel non-invasive technique in cases with MPN and its role in comparison to the standard bone marrow biopsy with regard to disease diagnosis, assessment of disease activity, detection of transformation, monitoring of treatment response and grading of fibrosis.Furthermore, we aim to study the association of FLT-PET uptake patterns with different genetic makeup (JAK2, CALR positive, MPL, or Triple negative disease) or allele burden in cases of Pre-PMF with the ability of FLT-PET to differentiate between Pre-PMF and ET. Although MPNs are diseases of elderly, MPN is diagnosed in younger age groups in a considerable number of cases. Since most of the available data as well as current WHO classification criteria emphases on the average MPN patients who range in age between 55 and 65 years. Less consistent data are available in the groups of patients presenting below this median age, such as children and younger adults which we're planning to reveal.

Official Title
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A Study of 18F-FLT Positron Emission Tomography (PET)/Computed Tomography Imaging in Pediatrics With Myeloproliferative Neoplasms

Conditions
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Essential Thrombocythemia, Primary Myelofibrosis, Fibrotic Stage, Primary Myelofibrosis, Prefibrotic Stage, Polycythemia Vera

Intervention / Treatment
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* Device: Diagnostic (18F-FLT PET/CT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cases fulfilling WHO (World Health Organization) 2016 diagnostic criteria for MPN including: Chronic myeloid leukemia, BCR-ABL1-positive (BCR-ABL = fusion gene from BCR (breakpoint cluster region gene/BCR gene product), Chronic neutrophilic leukemia (CNL), Polycythemia vera, Primary myelofibrosis prefibrotic/early stage, Primary myelofibrosis overt fibrotic stage, Essential thrombocythemia, Chronic eosinophilic leukemia, not otherwise specified (NOS) and Myeloproliferative neoplasm, unclassifiable. Age between 14 and 18 years old Patient accepts to sign inform consent ECOG (Eastern Cooperative Oncology Group) performance less than or equal 2 Exclusion Criteria: Patient not fulfilling the inclusion criteria. Vulnerable groups: pregnant, minors, prisoners will not be included.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-FLT PET/CT<br>Patients undergo 18F-FLT (3'-18Fluoro-3'-deoxy-Lthymidine) PET/CT (Positron Emission Tomography/ Computed Tomography) at baseline. No specific dietary restrictions or hydration are required for FLT-PET scans, however, patients will be urged to drink plenty of water before and after the PET studies. [18F] FLT will be prepared by the cyclotron core facility and assessed for quality control following good manufacturing practice criteria. The radiopharmaceutical will immediately be brought to the Molecular Imaging and Therapy Service Radiopharmacy for dispensation in the PET suite. For each scan, patients will receive approximately up to 370 MBq (target of 10 mCi) [18F] FLT by intravenous infusion. | Device: Diagnostic (18F-FLT PET/CT)<br>* The tracer compound [F-18] FLT will be injected into the patient's veins in a small volume of normal saline solution. The PET scan data collection is started immediately and is continued for 2 hours.<br>* Other names: Fluorothymidine F 18;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the uptake of 3'-deoxy-3'-[18F] fluorothymidine (FLT) positron emission tomography/computed tomography (PET) in children with MPNs | Evaluate the uptake of 3'-deoxy-3'-[18F] fluorothymidine (FLT) positron emission tomography/computed tomography (PET) imaging and it is value in assessing the malignant hematopoiesis in children with MPNs. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who have similar diagnosis and pattern between FLT and Bone Marrow | Assessing of WHO diagnostic criteria for diagnosing MPNs. Measurements would include: Bone marrow cellularity, trilineal assessment, megakaryocytic morphologic characteristics (atypia, clustering, size, lobulation), staging of primary myelofibrosis into prefibrotic/early stage, Primary myelofibrosis and overt fibrotic stage prefibrotic, grade of fibrosis, blast percentage, presence of transformation, intrasinusoidal hematopoiesis, dysplasia (if present). | 12 months |