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Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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: 1.
Megakaryocytic proliferation and atypia, without reticulin fibrosis > grade 1*, accompanied by increased age-adjusted BM cellularity, granulocytic proliferation and often decreased erythropoiesis. 2. 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. 3. Presence of JAK2, CALR or MPL mutation or in the absence of these mutations, presence of another clonal marker**or absence of minor reactive BM reticulin fibrosis. Minor criteria: Presence of at least one of the following, confirmed in two consecutive determinations: 1. Anemia not attributed to a comorbid condition. 2. Leukocytosis >11 x 109/L. 3. Palpable splenomegaly. 4. 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03116542
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hamad Medical Corporation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Qatar
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

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.

Arms & Interventions

Arms

Experimental: Diagnostic (18F-FLT PET/CT)

Patients undergo 18F-FLT (3'-18Fluoro-3'-deoxy-L-thymidine) 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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Doha, Qatar

Status

Recruiting

Address

National Center for Cancer Care & Research (NCCCR)

Doha, ,

Site Contact

Mohamed Yassin

yassin@hamad.qa

55037393

Nearest Location

Site Contact

Mohamed Yassin

yassin@hamad.qa

55037393

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