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MRI Assessment of Leukemia Response to Therapy

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ClinicalTrials.gov 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

Brief Summary:
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.

Condition or disease Intervention/treatment
Acute Myelogenous Leukemia Device: 3 Tesla (3T) Siemens Total imaging matrix (TIM) Trio whole-body system

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantitative DCE-MRI as a Predictor of Therapeutic Response in Acute Leukemia
Study Start Date : May 2012
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Group/Cohort Intervention/treatment
Acute Myelogenous Leukemia (AML)
Patients who have been diagnosed with AML
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)

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

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Ages Eligible for Study:   8 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537159

Contact: Alina Tudorica tudorica@ohsu.edu

United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Alina Tudorica       tudorica@ohsu.edu   
Principal Investigator: Wei Huang, PhD         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Principal Investigator: Wei Huang, PhD OHSU Knight Cancer Institute

Responsible Party: Wei Huang, Associate Professor, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01537159     History of Changes
Other Study ID Numbers: IRB00008123
HEM-11164-L ( Other Identifier: OHSU Knight Cancer Institute )
8123 ( Other Identifier: OHSU IRB )
First Posted: February 23, 2012    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017

Keywords provided by Wei Huang, OHSU Knight Cancer Institute:

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type