Quantitative MRI for Myelofibrosis

ConditionMyelofibrosis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-99

SponsorUniversity of Michigan Rogel Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

T1 Weighted MRI (magnetic resonance imaging)
Procedure/Surgery
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.

Treatment groups

192 Participants

are divided into 1 treatment group

Group A: T1 weighted MRI (magnetic resonance imaging)1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan Rogel Cancer Center

Lead sponsor

Sanofi

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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