Clinical trial NCT03121599: 18F-FLT (PET/CT) in Pediatrics With Myeloproliferative Neoplasms
Official title: A Study of 18F-FLT Positron Emission Tomography (PET)/Computed Tomography Imaging in Pediatrics With Myeloproliferative Neoplasms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Essential Thrombocythemia
Primary Myelofibrosis, Fibrotic Stage
Primary Myelofibrosis, Prefibrotic Stage
Polycythemia Vera
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-20
Enrollment: 3
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the uptake of 3'-deoxy-3'-[18F] fluorothymidine (FLT) positron emission tomography/computed tomography (PET) in children with MPNs
timeFrame: 12 Months
Secondary outcomes:
measure: Number of patients who have similar diagnosis and pattern between FLT and Bone Marrow
timeFrame: 12 months
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: National Center for Cancer Care & Research (NCCCR)
Study officials:
affiliation: Hamad Medical Corporation
name: Mohamed Yassin
role: PRINCIPAL_INVESTIGATOR
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