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Quantitative DCE-MRI as a Predictor of Therapeutic Response in Acute Leukemia


N/A
8 Years
75 Years
Open (Enrolling)
Both
Acute Myelogenous Leukemia

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Trial Information

Quantitative DCE-MRI as a Predictor of Therapeutic Response in Acute Leukemia


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Shutter-Speed Model

Outcome Description:

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.

Outcome Time Frame:

Up to 1 year

Safety Issue:

No

Principal Investigator

Wei Huang, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

8123

NCT ID:

NCT01537159

Start Date:

April 2012

Completion Date:

Related Keywords:

  • Acute Myelogenous Leukemia
  • AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Oregon Health and Science University Portland, Oregon  97201