MRI Assessment of Leukemia Response to Therapy
This study is currently recruiting participants.
Verified April 2013 by OHSU Knight Cancer Institute
Sponsor:
OHSU Knight Cancer Institute
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01537159
First received: February 14, 2012
Last updated: April 24, 2013
Last verified: April 2013
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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 Siemens TIM 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: | April 2012 |
| Estimated Primary Completion Date: | May 2013 (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 Siemens 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.
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 MDRD Equation)
- Pregnant women are excluded from this study because of possible risk to the fetus.
Contacts and Locations
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: | April 24, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by OHSU Knight Cancer Institute:
|
AML |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 22, 2013