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Completed

NCT Number: NCT01537159

MRI Assessment of Leukemia Response to Therapy

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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Key information

Conditions

Acute Myelogenous Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

8 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3 Tesla (3T) Siemens Total imaging matrix (TIM) Trio whole-body system

Device

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)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Registry information

Official study title

Quantitative DCE-MRI as a Predictor of Therapeutic Response in Acute Leukemia

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2012
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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