MRI Assessment of Leukemia Response to Therapy
- Conditions
- Acute Myelogenous Leukemia
- Interventions
- Device: 3 Tesla (3T) Siemens Total imaging matrix (TIM) Trio whole-body system
- Registration Number
- NCT01537159
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Acute Myelogenous Leukemia (AML) 3 Tesla (3T) Siemens Total imaging matrix (TIM) Trio whole-body system Patients who have been diagnosed with AML
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
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.
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.
Trial Locations
- Locations (1)
Oregon Health and Science University
🇺🇸Portland, Oregon, United States