Clinical trial NCT01537159: MRI Assessment of Leukemia Response to Therapy
Official title: Quantitative DCE-MRI as a Predictor of Therapeutic Response in Acute Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myelogenous Leukemia
Keywords: AML
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 23
Sex: ALL
Minimum age (years): 8
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

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.


Eligibility 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.

Primary outcomes:
measure: Shutter-Speed Model
timeFrame: Up to 1 year
Secondary outcomes:
measure: Pilot Data
timeFrame: Up to 1 year
measure: Complete Response
timeFrame: Up to 1 year
measure: Second SSM DCE-MRI
timeFrame: Up to 1 year
measure: DCE-MRI Biomarkers
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Wei Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References: