MRI Assessment of Leukemia Response to Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01537159
Recruitment Status : Recruiting
First Posted : February 23, 2012
Last Update Posted : August 4, 2017
Information provided by (Responsible Party):
Wei Huang, OHSU Knight Cancer Institute

February 14, 2012
February 23, 2012
August 4, 2017
May 2012
December 31, 2018   (Final data collection date for primary outcome measure)
Shutter-Speed Model [ Time Frame: Up to 1 year ]
To explore if Shutter-Speed Model (SSM) dynamic contrast-enhanced MRI (DCE-MRI)of the bone marrow (BM) can predict complete remission (CR) in newly diagnosed or relapsed acute myelogenous leukemia (AML)patients.
Same as current
Complete list of historical versions of study NCT01537159 on Archive Site
  • Pilot Data [ Time Frame: Up to 1 year ]
    To collect pilot data in SSM DCE-MRI assessment of AML response to therapy for the conduct of future studies.
  • Complete Response [ Time Frame: Up to 1 year ]
    To explore whether SSM DCE-MRI differs in predicting complete response (CR) for the newly diagnosed AML patients and for the relapsed AML patients.
  • Second SSM DCE-MRI [ Time Frame: Up to 1 year ]
    To explore if the second SSM DCE-MRI and/or changes between the first and second imaging studies can predict CR in the non-CR group who undergo an additional therapy.
  • DCE-MRI Biomarkers [ Time Frame: Up to 1 year ]
    To compare/correlate/combine DCE-MRI bio-markers with micro-vascular density (MVD) and proangiogenic cytokine profiles for the purpose of predicting response of AML patients to therapy.
Same as current
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MRI Assessment of Leukemia Response to Therapy
Quantitative DCE-MRI as a Predictor of Therapeutic Response in Acute Leukemia
The purpose of this study is to investigate if a type of magnetic resonance imaging (MRI) scan of the bone marrow before the start of standard chemotherapy can predict complete remission of leukemia patients after the therapy. This type of MRI scan, called dynamic contrast-enhanced MRI (DCE-MRI), measures bone marrow blood flow. For those patients who do not achieve complete remission status after initial therapy and will be treated with additional therapy, the investigators are also interested in determining if the second MRI exam before the additional therapy can predict complete remission. If successfully tested, the MRI exam may be used in the future to help with early identification of patients who are unlikely to respond to standard chemotherapy. This will allow for a personalized therapeutic plan to be developed for these patients at an early stage and prevent them from being exposed to toxic and ineffective therapies.
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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Primary Care Clinic
Acute Myelogenous Leukemia
Device: 3 Tesla (3T) Siemens Total imaging matrix (TIM) Trio whole-body system
Each MR scanning session will include the pre-contrast multi-slice T2-weighted MRI with fat-saturation and T1-weighted MRI which are regularly acquired in clinical protocols. Following these acquisitions, high-spatial and temporal-resolution DCE-MRI will be performed. The total duration of a research MR session is expected to be less than 45 min.
Other Name: Magnetic Resonance Imaging (MRI)
Acute Myelogenous Leukemia (AML)
Patients who have been diagnosed with AML
Intervention: Device: 3 Tesla (3T) Siemens Total imaging matrix (TIM) Trio whole-body system
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 31, 2018
December 31, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Newly diagnosed or relapsed AML patients, who are scheduled to receive standard induction therapy.
  • Age > 8 years and requiring no sedation.
  • Patients must not be pregnant
  • Women of childbearing potential must have negative serum pregnancy test performed within 7-days prior to start of study
  • The subject or subject's legal guardian has the ability to understand and the willingness to sign a written informed consent and/or assent document. A signed study-specific informed consent and/or assent must be obtained prior to any study specific procedures.

Exclusion Criteria:

  • Patients who would be normally excluded from undergoing an MRI examination - patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field.
  • Patients who have known or suspected allergy to gadolinium-based contrast agent.
  • Severe claustrophobia precluding subject from undergoing a MRI
  • Patients with acute or chronic kidney dysfunction (estimated Glomerular Filtration Rate (eGFR) < 30ml/min/1.73 m2 as calculated using the Modification of Diet in Renal Disease (MDRD) Equation)
  • Pregnant women are excluded from this study because of possible risk to the fetus.
Sexes Eligible for Study: All
8 Years to 75 Years   (Child, Adult, Senior)
Contact: Alina Tudorica
United States
HEM-11164-L ( Other Identifier: OHSU Knight Cancer Institute )
8123 ( Other Identifier: OHSU IRB )
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Wei Huang, OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
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Principal Investigator: Wei Huang, PhD OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
August 2017