Quantitative MRI for Myelofibrosis

NCT01973881 | Recruiting DMC

• 3 other identifiers: UMCC 2014.034R01CA238023HUM00077505
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelofibrosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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)

Interventions

T1 Weighted MRI (magnetic resonance imaging) PROCEDURE

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.

T1 weighted MRI (magnetic resonance imaging)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Sanofi: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Primary Myelofibrosis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Gary Luker, M.D.

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gary Luker, M.D.

CONTACT

734-763-5476; gluker@umich.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 1, 2013
• Study Start: December 22, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)