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

NCT03116542 | Unknown DMC FDA Device

• 1 other identifier: 16287/16
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of patients with 50% or more uptake of FLT-PET in patients with Prefibrotic/Early Primary Myelofibrosis (PMF) and Essential Thrombocythemia (ET) 12 months from the baseline

  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 patients with Prefibrotic/Early Primary Myelofibrosis (PMF) and Essential Thrombocythemia (ET).

  12 Months

Secondary Outcomes (1)

• Reduction in at least 50% of the allele burden of different mutations (JAK-2, MPL, CALR) and its expression on FLT- PET uptake pattern 12 moths from the baseline

  12 Months

Study Arms (1)

Diagnostic (18F-FLT PET/CT)

EXPERIMENTAL

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.

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

Interventions

Diagnostic (18F-FLT PET/CT) DEVICE

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.

Also known as: 18F-FLT PET/CT, 3'-Deoxy-3'-(18F) Fluorothymidine, 3'-deoxy-3'-[18F]fluorothymidine, Fluorothymidine F 18

Diagnostic (18F-FLT PET/CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 marker\*\*or 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

National Center for Cancer Care & Research (NCCCR)

Doha, Qatar

RECRUITING

Related Publications (14)

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  PMID: 18758298 BACKGROUND

• Yassin MA, Nehmeh SA, Nashwan AJ, Kohla SA, Mohamed SF, Ismail OM, Sabbagh AA, Ibrahim F, Soliman DS, Szabados L, Fayad H. A study of 18F-FLT positron emission tomography/computed tomography imaging in cases of prefibrotic/early primary myelofibrosis and essential thrombocythemia. Medicine (Baltimore). 2020 Nov 6;99(45):e23088. doi: 10.1097/MD.0000000000023088.

  PMID: 33157979 DERIVED

MeSH Terms

Conditions

Thrombocythemia, Essential; Primary Myelofibrosis

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombocytosis; Blood Platelet Disorders; Myeloproliferative Disorders; Bone Marrow Diseases; Hemorrhagic Disorders

Central Study Contacts

Mohamed Yassin

CONTACT

55037393; yassin@hamad.qa

Abdulqadir Nashwan

CONTACT

66473549; anashwan@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 17, 2017
• Study Start: May 7, 2017
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 29, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)