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

This study is currently recruiting participants.
Verified July 2017 by Hamad Medical Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT03121599
First Posted: April 20, 2017
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hamad Medical Corporation
  Purpose

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 Intervention
Essential Thrombocythemia Primary Myelofibrosis, Fibrotic Stage Primary Myelofibrosis, Prefibrotic Stage Polycythemia Vera Device: Diagnostic (18F-FLT PET/CT)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Study of 18F-FLT Positron Emission Tomography (PET)/Computed Tomography Imaging in Pediatrics With Myeloproliferative Neoplasms

Resource links provided by NLM:


Further study details as provided by Hamad Medical Corporation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 20
Actual Study Start Date: June 11, 2017
Estimated Study Completion Date: June 1, 2018
Estimated Primary Completion Date: May 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • 18F-FLT PET/CT
  • 3'-Deoxy-3'-(18F) Fluorothymidine
  • 3'-deoxy-3'-[18F]fluorothymidine
  • Fluorothymidine F 18

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Mohamed Yassin 55037393 yassin@hamad.qa
Contact: Abdulqadir Nashwan 66473549 anashwan@hamad.qa

Locations
Qatar
National Center for Cancer Care & Research (NCCCR) Recruiting
Doha, Qatar
Contact: Abdulqadir Nashwan    66473549    anashwan@hamad.qa   
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         
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
Principal Investigator: Mohamed Yassin Hamad Medical Corporation
  More Information

Publications:

Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT03121599     History of Changes
Other Study ID Numbers: 16294/16
First Submitted: April 17, 2017
First Posted: April 20, 2017
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Neoplasms
Primary Myelofibrosis
Polycythemia
Polycythemia Vera
Thrombocytosis
Myeloproliferative Disorders
Thrombocythemia, Essential
Bone Marrow Diseases
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders
Alovudine
Antiviral Agents
Anti-Infective Agents