MRI Assessment of Leukemia Response to Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 30, 2014
Last verified: May 2014
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantitative DCE-MRI as a Predictor of Therapeutic Response in Acute Leukemia

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Acute Myelogenous Leukemia (AML)
Patients who have been diagnosed with AML
Device: 3T (3 Tesla) Siemens TIM (Total imaging matrix) 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)

  Eligibility

Ages Eligible for Study:   8 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary Care Clinic

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537159

Contacts
Contact: Aneela Afzal afzal@ohsu.edu

Locations
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Aneela Afzal       afzal@ohsu.edu   
Principal Investigator: Wei Huang, PhD         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Wei Huang, PhD OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01537159     History of Changes
Other Study ID Numbers: 8123, HEM-11164-L
Study First Received: February 14, 2012
Last Updated: May 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by OHSU Knight Cancer Institute:
AML

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

ClinicalTrials.gov processed this record on October 01, 2014