Quantitative MRI for Myelofibrosis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myelofibrosis
• Intervention / Treatment: Procedure: T1 Weighted MRI (magnetic resonance imaging)

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 Type: Observational
• Enrollment (Estimated): 192

Contacts and Locations

• Study Contact: Name: Gary Luker, M.D.; Phone Number: 734-763-5476; Email: gluker@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Hospital
      • Contact: Gary Luker, M.D.; Phone Number: 734-763-5476; Email: gluker@umich.edu
      • Principal Investigator: Gary Luker, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People diagnosed with myelofibrosis who are able to undergo an MRI without anesthesia.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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 physical examinations, laboratory testing, and other indicated imaging examinations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Using MRI to assess treatment response in subjects with myelofibrosis	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.	5 years

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: National Cancer Institute (NCI); Sanofi
• Investigators: Principal Investigator: Gary Luker, M.D., University of Michigan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: October 25, 2013
• First Posted (Estimated): November 1, 2013

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Bone Marrow Diseases; Myeloproliferative Disorders; Primary Myelofibrosis
• Other Study ID Numbers: UMCC 2014.034; HUM00077505 (Other Identifier: University of Michigan); R01CA238023 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO