Quantitative MRI for Myelofibrosis

Recruiting

• Conditions: Myelofibrosis
• Interventions: Procedure: T1 Weighted MRI (magnetic resonance imaging)

• Registration Number: NCT01973881
• Lead Sponsor: University of Michigan

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-10-25
• Study First Posted: 2013-11-01
• Study Start: 2014-12-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

1. Male /female subjects over the age of 18

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

1. 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.

2. Any prior adverse event associated with MRI that is not related to injection of contrast agents or other medicines.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T1 weighted MRI (magnetic resonance imaging)	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.

Primary Outcome Measures

Name	Time	Method
Using MRI to assess treatment response in subjects with myelofibrosis	5 years	For the development and validation of functional magnetic resonance imaging 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.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States