Recruiting NCT01973881

Quantitative MRI for Myelofibrosis

— Observational Myelofibrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: T1 Weighted MRI (magnetic resonance imaging).
Who it may be relevant to: Registry conditions: Myelofibrosis. Basic parameters: 18 years — 99 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Quantitative MRI for Myelofibrosis - MRI Parameters as Biomarkers for Analyzing Extent of Disease and Measuring Response to Treatment

Overview

Detailed description

This study is 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. This research will lay the foundation for larger clinical trials using MRI to assess and predict effects of existing and new therapeutic agents for patients with myelofibrosis.

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.

Interventions

Procedure 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 physi

Primary outcome measures

Using MRI to assess treatment response in subjects with myelofibrosis [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

Male /female subjects over the age of 18
Diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.
No contraindications to MRI
Able to undergo MRI without anesthesia

Exclusion criteria

Patients with pacemakers or other implanted magnetic devices that may malfunction or move because of the strong magnetic field inside the MRI room and scanner.
Any prior adverse event associated with MRI that is not related to injection of contrast agents or other medicines.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Case-only

Study locations

United States · 1 center

University of Michigan Hospital — Ann Arbor

Publications

Robison TH, Levinson A, Lee W, Pettit K, Malyarenko D, Kandarpa M, Johnson TD, Chenevert TL, Ross BD, Talpaz M, Luker GD. Quantitative MRI Assessment of Bone Marrow Disease in Myelofibrosis: A Prospective Study. Radiol Imaging Cancer. 2025 Nov;7(6):e240501. doi: 10.1148/rycan.240501. PMID 41236389

Identifiers

NCT: NCT01973881 · UMCC 2014.034 · R01CA238023 · HUM00077505

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗