Clinical trial NCT01973881: Quantitative MRI for Myelofibrosis
Official title: Quantitative MRI for Myelofibrosis - MRI Parameters as Biomarkers for Analyzing Extent of Disease and Measuring Response to Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myelofibrosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Sanofi
name: National Cancer Institute (NCI)
First posted: 2013-11-01
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People diagnosed with myelofibrosis who are able to undergo an MRI without anesthesia.

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.

Eligibility criteria: 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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Primary outcomes:
measure: Using MRI to assess treatment response in subjects with myelofibrosis
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Gary Luker, M.D.
role: PRINCIPAL_INVESTIGATOR
References: