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

Primary Purpose

Essential Thrombocythemia, Primary Myelofibrosis, Fibrotic Stage, Primary Myelofibrosis, Prefibrotic Stage

Status
Terminated
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Diagnostic (18F-FLT PET/CT)
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Essential Thrombocythemia

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Center for Cancer Care & Research (NCCCR)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-FLT PET/CT

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
April 17, 2017
Last Updated
August 10, 2020
Sponsor
Hamad Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03121599
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Delayed study materials, poor recruitment
Study Start Date
June 11, 2017 (Actual)
Primary Completion Date
October 15, 2018 (Actual)
Study Completion Date
October 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Thrombocythemia, Primary Myelofibrosis, Fibrotic Stage, Primary Myelofibrosis, Prefibrotic Stage, Polycythemia Vera

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-FLT PET/CT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Diagnostic (18F-FLT PET/CT)
Other Intervention Name(s)
18F-FLT PET/CT, 3'-Deoxy-3'-(18F) Fluorothymidine, 3'-deoxy-3'-[18F]fluorothymidine, Fluorothymidine F 18
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the uptake of 3'-deoxy-3'-[18F] fluorothymidine (FLT) positron emission tomography/computed tomography (PET) in children with MPNs
Description
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.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Number of patients who have similar diagnosis and pattern between FLT and Bone Marrow
Description
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).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Yassin
Organizational Affiliation
Hamad Medical Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center for Cancer Care & Research (NCCCR)
City
Doha
Country
Qatar

12. IPD Sharing Statement

Plan to Share IPD
No
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18F-FLT (PET/CT) in Pediatrics With Myeloproliferative Neoplasms

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