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MRI Assessment of Leukemia Response to Therapy

Sponsor
OHSU Knight Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01537159
Collaborator
(none)
23
Enrollment
1
Location
80
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: 3 Tesla (3T) Siemens Total imaging matrix (TIM) Trio whole-body system

Study Design

Study Type:
Observational
Actual Enrollment :
23 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 1, 2012
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm 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 Names:
  • Magnetic Resonance Imaging (MRI)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Shutter-Speed Model [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oregon Health and Science University Portland Oregon United States 97239

    Sponsors and Collaborators

    • OHSU Knight Cancer Institute

    Investigators

    • Principal Investigator: Wei Huang, PhD, OHSU Knight Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wei Huang, Associate Professor, OHSU Knight Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT01537159
    Other Study ID Numbers:
    • IRB00008123
    • HEM-11164-L
    • 8123
    First Posted:
    Feb 23, 2012
    Last Update Posted:
    Jul 30, 2019
    Last Verified:
    Jul 1, 2019
    Keywords provided by Wei Huang, Associate Professor, OHSU Knight Cancer Institute
    AML
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute

    Study Results

    No Results Posted as of Jul 30, 2019