Optimization of Novel DCE-MRI Imaging Sequences for Cancer Therapy Monitoring
Procedure: dynamic contrast-enhanced magnetic resonance imaging
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Optimization of Novel DCE-MRI Imaging Sequences for Cancer Therapy Monitoring|
- Dynamic contrast-enhanced MRI (DCE-MRI) as a measure of tumor treatment response. [ Time Frame: 1 year ] [ Designated as safety issue: No ]Analysis of DCE-MRI data will be by semi-quantitative metrics such as the area under the curve (AUC), the slopes of contrast agent uptake and washout curves as well as peak contrast agent uptake. Alternatively quantitative metrics based upon pharmacokinetic modeling will be derived. The model is the 2-compartment Kety model from which volume transfer constants between compartments and volume of the tissue compartments can be calculated.
|Study Start Date:||November 2012|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Experimental: DCE-MRI (dynamic contrast-enhanced MRI)
Patients undergo DCE-MRI over approximately 30-60 minutes consisting of an anatomical scout image to localize the region of interest, a set of pre-injection scans to calibrate the dynamic image set, a dynamic image set during which contrast agent will be injected, and a set of post-injection scans to calibrate the DCE-MRI database.
Other Name: Gadobenate dimeglumineProcedure: dynamic contrast-enhanced magnetic resonance imaging
Undergo DCE-MRI using new pulse sequences
Other Name: DCE-MRI
I. Optimize and develop functional DCE-MRI pulse sequences, which involve the injection of MRI-visible contrast agents, for imaging in the head/neck, abdominal and pelvic regions.
II. Determine the ideal radiofrequency (RF) coil setup to maximize signal to noise ratio of the optimized pulse sequences.
III. Distill the findings of specific aims 1 and 2 into streamlined protocols that can be used in subsequent studies for cancer phenotyping and treatment monitoring in a quantitative manner.
IV. To establish a virtual reference image repository for future studies.
OUTLINE: Patients undergo DCE-MRI over approximately 30-60 minutes consisting of an anatomical scout image to localize the region of interest, a set of pre-injection scans to calibrate the dynamic image set, a dynamic image set during which contrast agent will be injected, and a set of post-injection scans to calibrate the DCE-MRI database.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752231
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|Principal Investigator:||Jinha Park, MD, Ph.D.||City of Hope Medical Center|