18F-FLT (PET/CT) in Pediatrics With Myeloproliferative Neoplasms
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|ClinicalTrials.gov Identifier: NCT03121599|
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : September 5, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Essential Thrombocythemia Primary Myelofibrosis, Fibrotic Stage Primary Myelofibrosis, Prefibrotic Stage Polycythemia Vera||Device: Diagnostic (18F-FLT PET/CT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of 18F-FLT Positron Emission Tomography (PET)/Computed Tomography Imaging in Pediatrics With Myeloproliferative Neoplasms|
|Actual Study Start Date :||June 11, 2017|
|Estimated Primary Completion Date :||May 1, 2019|
|Estimated Study Completion Date :||June 1, 2019|
Experimental: 18F-FLT PET/CT
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)
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.
- Evaluate the uptake of 3'-deoxy-3'-[18F] fluorothymidine (FLT) positron emission tomography/computed tomography (PET) in children with MPNs [ Time Frame: 12 Months ]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.
- Number of patients who have similar diagnosis and pattern between FLT and Bone Marrow [ Time Frame: 12 months ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03121599
|Contact: Mohamed Yassinfirstname.lastname@example.org|
|Contact: Abdulqadir Nashwanemail@example.com|
|National Center for Cancer Care & Research (NCCCR)||Recruiting|
|Contact: Abdulqadir Nashwan 66473549 firstname.lastname@example.org|
|Principal Investigator: Mohamed A Yassin|
|Sub-Investigator: Ahmad Al Sabbagh|
|Sub-Investigator: Firyal Ibrahim|
|Sub-Investigator: Dina Soliman|
|Sub-Investigator: Samah Kohla|
|Sub-Investigator: Sadek Nehmeh|
|Sub-Investigator: Lajos Szabados|
|Sub-Investigator: Stefan Guhlke|
|Sub-Investigator: Halima El-Omari|
|Sub-Investigator: Shehab Mohamed|
|Sub-Investigator: Omar Ismail|
|Sub-Investigator: Abdulqadir J. Nashwan|
|Principal Investigator:||Mohamed Yassin||Hamad Medical Corporation|