Recruiting

MRI

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT01973881

Conditions

Myelofibrosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

T1 Weighted MRI (magnetic resonance imaging)

Study Details

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

Study ID

NCT01973881

Start date

Dec 22, 2014

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

192 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Michigan Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Gary Luker, M.D.

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-07-31.