Optimization of Novel DCE-MRI Imaging Sequences for Cancer Therapy Monitoring
18 Years
N/A
Both
Normal Volunteers
Trial Information
Optimization of Novel DCE-MRI Imaging Sequences for Cancer Therapy Monitoring
PRIMARY OBJECTIVES:
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.
Inclusion Criteria:
All subjects are eligible except for the following special cases:
Exclusion Criteria:
- Female subjects who are or may be pregnant will NOT be eligible.
- The minimum age for all subjects is 18 years old. No subjects under the age of 18
shall be considered.
- If subject has received an imaging contrast agent of any kind within the past 7 days,
they shall not be included in the study.
- Subjects for whom MRI is contraindicated as set forth by the City of Hope Department
of Radiology. These include:
- electrical implants such as cardiac pacemakers or perfusion pumps
- ferromagnetic implants such as aneurysm clips, surgical clips, prostheses,
artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos
near the eye, or steel implants
- ferromagnetic objects such as jewelry or metal clips in clothing
- pre-existing medical conditions, including a likelihood of developing seizures
or anxiety disorders such as claustrophobia, panic attacks or any psychiatric
disorder
- any greater than normal potential for cardiac arrest
- any subject with known kidney insufficiency function as evidenced by an abnormal
serum creatinine (normal = 0.6 - 1.5 mg/dL) from a blood test performed on the
subject within the past 6 months of the study date.
- Any subject with abnormal creatinine clearance (normal = 100-130 ml/min/1.73m2),
as measured by a direct test or from plasma creatinine (14) levels shall be
excluded.
- Normal subjects with a history of severe claustrophobia will not be eligible.
- For ease of recruiting and study management purposes, only subjects who can give
consent in English shall be eligible for this study.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Dynamic contrast-enhanced MRI (DCE-MRI) as a measure of tumor treatment response.
Outcome Description:
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.
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Jinha Park, MD, Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
City of Hope Medical Center
Authority:
United States: Institutional Review Board
Study ID:
12050
NCT ID:
NCT01752231
Start Date:
November 2012
Completion Date:
Related Keywords:
- Normal Volunteers
Name | Location |
|---|---|
| City of Hope Medical Center | Duarte, California 91010 |
