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Trial record 1 of 1 for:    NCT01973881
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Quantitative MRI for Myelofibrosis

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Gary Luker M.D., University of Michigan
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Gary Luker M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT01973881
First received: October 25, 2013
Last updated: June 15, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Myelofibrosis Procedure: T1 Weighted MRI (magnetic resonance imaging)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quantitative MRI for Myelofibrosis - MRI Parameters as Biomarkers for Analyzing Extent of Disease and Measuring Response to Treatment

Resource links provided by NLM:


Further study details as provided by Gary Luker M.D., University of Michigan:

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


Estimated Enrollment: 120
Study Start Date: December 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


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

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People diagnosed with myelofibrosis who are able to undergo an MRI without anesthesia.
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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01973881

Contacts
Contact: Gary Luker, M.D. 734-763-5476 gluker@umich.edu

Locations
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Gary Luker, M.D.    734-763-5476    gluker@umich.edu   
Principal Investigator: Gary Luker, M.D.         
Sponsors and Collaborators
University of Michigan
Sanofi
Investigators
Principal Investigator: Gary Luker, M.D. University of Michigan Hospital
  More Information

Responsible Party: Gary Luker M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01973881     History of Changes
Other Study ID Numbers: HUM00077505
Study First Received: October 25, 2013
Last Updated: June 15, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on September 21, 2017