MRI Assessment of Leukemia Response to Therapy
Conditions
Acute Myelogenous Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
AML
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: 3 Tesla (3T) Siemens Total imaging matrix (TIM) Trio whole-body system
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 8 Years
Gender: Both
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.
Location
Oregon Health and Science University
Portland, Oregon, United States
Status: Recruiting
Contact: Aneela Afzal - afzal@ohsu.edu
Start Date
May 2012
Sponsors
OHSU Knight Cancer Institute
Source
OHSU Knight Cancer Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page