18F-FLT (PET/CT) in Prefibrotic/Early Primary Myelofibrosis and Essential Thrombocythemia

  • STATUS
    Recruiting
  • days left to enroll
    66
  • participants needed
    21
  • sponsor
    Hamad Medical Corporation
Updated on 26 January 2021
platelet count
chronic myeloid leukemia
anemia
myelofibrosis
leukemia
bone marrow biopsy
polycythemia vera
thrombocytosis
myelogenous leukemia

Summary

The main purpose of this project is to study the uptake pattern of FLT-PET in cases, and it is value in assessing the malignant hematopoiesis in cases of Pre-PMF and ET, regarding diagnosis, staging and monitoring response to therapy. Identifying different patterns of uptake in patients with Pre-PMF and ET in various clinical settings.

Evaluating FLT-PET as a novel non-invasive technique in cases with Pre-PMF and ET, in comparison to the standard bone marrow biopsy about disease diagnosis, assessment of disease activity, detection of transformation, monitoring of treatment response and grading of fibrosis.Study the ability of FLT-PET to differentiate between Pre-PMF and ET.

the investigators also aim to examine the association of FLT-PET uptake patterns with different genetic makeup (JAK2 (Janus kinase 2), CALR (Calreticulin), MPL (myeloproliferative leukemia protein), or Triple negative disease) or allele burden in cases of Pre-PMF and ET.

Description

PET with fluorodeoxy glucose combined with computed tomography is a major tool for the diagnosis, staging, and monitoring of treatment response in clinical oncology. 3'-18Fluoro-3'-deoxy-L-thymidine (18F-FLT) is a PET radiotracer that quickly accumulates in proliferating cells and can be used to assess tumor cell proliferation in various cancers as PET radiotracer offers a non-invasive assessment of cell proliferation in vivo.

Myeloproliferative Neoplasms (MPNs) are clonal hematopoietic stem disorders characterized by high rate of effective proliferation of one or more cell lineage. MPNs are overlapping syndromes that can progress to fibrotic stage or evolute into acute leukemia. Preliminary results of a pilot study (5) suggested that this technique could be useful to assess bone marrow (BM) activity and extramedullary hematopoiesis in patients with Myelofibrosis (MF).

The current standard for follow- up of these patients is based on pathological markers (peripheral blood counts and/ bone marrow histomorphology) and molecular markers. Although, bone marrow examination could be considered as a standard gold method as it gives detailed information about cellularity, the morphology of each lineage, a degree of fibrosis, transformation and dysplastic features. However, many patients are reluctant to go for this invasive technique which precludes precise assessment of disease activity at the desirable frequencies. Non- invasive techniques which may act as the good clinical surrogate are lacking.

The objective of this study is to study the uptake pattern of FLT-PET in cases, and it is value in assessing the malignant hematopoiesis in cases of Pre-PMF and ET, regarding diagnosis, staging and monitoring response to therapy.

Identifying different patterns of uptake in patients with Pre-PMF and ET in various clinical settings.

Evaluating FLT-PET as a novel non-invasive technique in cases with Pre-PMF and ET, in comparison to the standard bone marrow biopsy about disease diagnosis, assessment of disease activity, detection of transformation, monitoring of treatment response and grading of fibrosis.

Study the ability of FLT-PET to differentiate between Pre-PMF and ET. the investigators also aim to investigate the association of FLT-PET uptake patterns with different genetic makeup (JAK2, CALR, MPL, or Triple negative disease) or allele burden in cases of Pre-PMF and ET.

Details
Condition ESSENTIAL THROMBOCYTHEMIA, Primary Myelofibrosis, Fibrotic Stage, Primary Myelofibrosis, Prefibrotic Stage, Primary Myelofibrosis, Fibrotic Stage, Primary Myelofibrosis, Prefibrotic Stage, Primary Myelofibrosis, Fibrotic Stage, Primary Myelofibrosis, Prefibrotic Stage, Primary Myelofibrosis, Fibrotic Stage, Primary Myelofibrosis, Prefibrotic Stage, Primary Myelofibrosis, Fibrotic Stage, Primary Myelofibrosis, Prefibrotic Stage, Primary Myelofibrosis, Fibrotic Stage, Primary Myelofibrosis, Prefibrotic Stage, Primary Myelofibrosis, Fibrotic Stage, Primary Myelofibrosis, Prefibrotic Stage
Treatment Diagnostic (18F-FLT PET/CT)
Clinical Study IdentifierNCT03116542
SponsorHamad Medical Corporation
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 year old or above Patient accept to sign inform consent ECOG (Eastern
Cooperative Oncology Group) performance less than or equal 2
Cases fulfilling WHO (World Health Organization) 2016 diagnostic criteria for PMF
WHO criteria for prefibrotic/early primary myelofibrosis (prePMF)
Major criteria
Megakaryocytic proliferation and atypia, without reticulin fibrosis > grade 1, accompanied by increased age-adjusted BM cellularity, granulocytic proliferation and often decreased erythropoiesis
Not meeting the WHO criteria for BCR-ABL1+ ((BCR-ABL = fusion gene from BCR (breakpoint cluster region gene/BCR gene product) and ABL (Abelson proto-oncogene)) CML (chronic myelogenous leukemia), PV (Polycythemia Vera), ET, myelodysplastic syndromes, or other myeloid neoplasms
Presence of JAK2, CALR or MPL mutation or in the absence of these mutations, presence of another clonal markeror absence of minor reactive BM reticulin fibrosis
Minor criteria
Presence of at least one of the following, confirmed in two consecutive
determinations
Anemia not attributed to a comorbid condition
Leukocytosis >11 x 109/L
Palpable splenomegaly
LDH (Lactate dehydrogenase) increased to above upper normal limit of institutional reference range
Diagnosis of prePMF requires meeting all three major criteria, and at least
one minor criterion in the absence of any of the 3 major clonal mutations
the search for the most frequent accompanying gene mutations (e.g. ASXL1
EZH2, TET2, IDH1/IDH2, SRSF2, SF3B1) are of help in determining the clonal
nature of the disease
minor (grade 1) reticulin fibrosis secondary to infection, autoimmune
disorder or other chronic inflammatory conditions, hairy cell leukemia or
other lymphoid neoplasm, metastatic malignancy, or toxic (chronic)
myelopathies
WHO diagnostic criteria essential thrombocythemia Major criteria Platelet
count 450 109/L Bone marrow biopsy showing proliferation mainly of the
megakaryocyte lineage with increased numbers of enlarged, mature
megakaryocytes with hyperlobulated nuclei. No significant increase or left
shift in neutrophil granulopoiesis or erythropoiesis and very rarely minor
(grade 1) increase in reticulin fibers
Not meeting WHO criteria for BCR-ABL1+ CML, PV, PMF, myelodysplastic
syndromes, or other myeloid neoplasms Presence of JAK2, CALR, or MPL mutation
Minor criterion Presence of a clonal marker or absence of evidence for
reactive thrombocytosis Diagnosis of ET requires meeting all 4 major criteria
or the first 3 major criteria and the minor criterion

Exclusion Criteria

Patient not fulfilling the inclusion criteria
Vulnerable groups: pregnant, minors, prisoners will not be included
Bone marrow will be collected as part of the routine diagnostic work-up. No extra bone marrow material will be collected solely for the aim of the study
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