Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
192 participants
OBSERVATIONAL
2014-12-22
2026-12-31
Brief Summary
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Detailed Description
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This study proposes that more advanced MRI techniques currently used in clinical medicine can be applied to enable response to therapy to be determined earlier than currently is possible for patients with myelofibrosis. In particular, this study is designed to determine to what extent abnormalities in diffusion of water molecules (diffusion MRI) and/or fat content in bone marrow (T1-weighted imaging) define extent of initial disease and serve as early predictors of response to therapy.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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T1 weighted MRI (magnetic resonance imaging)
For the development and validation of functional magnetic resonance imaging (MRI) parameters as biomarkers for analyzing extent of disease and quantifying response to treatment in patients with myelofibrosis. Quantitative MRI parameters for diffusion of water and/or fat content in bone marrow will determine extent of disease in patients with myelofibrosis, and changes in these parameters will predict response to therapy. To investigate this hypothesis, the researchers will perform this pilot clinical study of diffusion and fat content (T1 weighted imaging) in patients before and during treatment for myelofibrosis. The researchers expect to identify MRI parameters that determine the extent and severity of bone marrow disease in these patients and determine response to therapy at earlier time points than currently used clinical parameters.
T1 Weighted MRI (magnetic resonance imaging)
Enrolled subjects will have an MRI scan performed at baseline (within 1 month before beginning therapy), at the time of a scheduled bone marrow biopsy or end of treatment cycle (6 months), and after 12 months.
Please note: Patients in this study will be treated with chemotherapy as determined by the hematologist or the treatment protocol for an independent clinical trial for therapy of myelofibrosis. Treatment and monitoring will be performed under the usual standard of care that includes physical examinations, laboratory testing, and other indicated imaging examinations.
Interventions
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T1 Weighted MRI (magnetic resonance imaging)
Enrolled subjects will have an MRI scan performed at baseline (within 1 month before beginning therapy), at the time of a scheduled bone marrow biopsy or end of treatment cycle (6 months), and after 12 months.
Please note: Patients in this study will be treated with chemotherapy as determined by the hematologist or the treatment protocol for an independent clinical trial for therapy of myelofibrosis. Treatment and monitoring will be performed under the usual standard of care that includes physical examinations, laboratory testing, and other indicated imaging examinations.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.
3. No contraindications to MRI
4. Able to undergo MRI without anesthesia
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Exclusion Criteria
2. Any prior adverse event associated with MRI that is not related to injection of contrast agents or other medicines.
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18 Years
99 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
National Cancer Institute (NCI)
NIH
University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Gary Luker, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Hospital
Locations
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University of Michigan Hospital
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00077505
Identifier Type: OTHER
Identifier Source: secondary_id
UMCC 2014.034
Identifier Type: -
Identifier Source: org_study_id
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