MRI Assessment of Leukemia Response to Therapy

Acute Myelogenous Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537159
• Other study ID #: IRB00008123
• Secondary ID: HEM-11164-L8123
• Status: Completed
• Start date: May 2012
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2019
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• 3 Tesla (3T) Siemens Total imaging matrix (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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shutter-Speed Model	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.	Up to 1 year
Secondary	Pilot Data	To collect pilot data in SSM DCE-MRI assessment of AML response to therapy for the conduct of future studies.	Up to 1 year
Secondary	Complete Response	To explore whether SSM DCE-MRI differs in predicting complete response (CR) for the newly diagnosed AML patients and for the relapsed AML patients.	Up to 1 year
Secondary	Second SSM DCE-MRI	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.	Up to 1 year
Secondary	DCE-MRI Biomarkers	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.	Up to 1 year