MRI Assessment of Leukemia Response to Therapy

This study is currently recruiting participants.
Verified November 2013 by OHSU Knight Cancer Institute
Sponsor:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01537159
First received: February 14, 2012
Last updated: November 7, 2013
Last verified: November 2013

February 14, 2012
November 7, 2013
May 2012
June 2014   (final data collection date for primary outcome measure)
Shutter-Speed Model [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
  • Pilot Data [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Primary Care Clinic

Acute Myelogenous Leukemia
Device: 3T Siemens 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: 3T Siemens TIM Trio whole-body system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
June 2014   (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 MDRD Equation)
  • Pregnant women are excluded from this study because of possible risk to the fetus.
Both
8 Years to 75 Years
No
Contact: Aneela Afzal afzal@ohsu.edu
United States
 
NCT01537159
8123, HEM-11164-L
Yes
OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
Not Provided
Principal Investigator: Wei Huang, PhD OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP