MRI Assessment of Leukemia Response to Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

FDG PET and DCE-MRI in Predicting Response to Treatment in Patients With Breast Cancer

NCT01931709

Male Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer +1 more

TERMINATED NA

PET and/or MRI Scans in Assessing Tumor Response in Patients Receiving Antiangiogenesis Therapy

NCT00019565

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

DCE MRI in Patients With Pancreatic Cancer

NCT02070705

Familial Pancreatic Cancer Pancreatic Adenocarcinoma Pancreatic Intraductal Papillary-Mucinous Neoplasm

TERMINATED NA

Optimization of Novel DCE-MRI Imaging Sequences for Cancer Therapy Monitoring

NCT01752231

Normal Volunteers

TERMINATED

Dynamic Contrast Enhanced MRI(DCE-MRI)of Bone Tumors

NCT00598741

Sarcoma Bone Tumor

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myelogenous Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acute Myelogenous Leukemia (AML)

Patients who have been diagnosed with AML

3 Tesla (3T) Siemens Total imaging matrix (TIM) Trio whole-body system

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Magnetic Resonance Imaging (MRI)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No