- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01752231
Optimization of Novel DCE-MRI Imaging Sequences for Cancer Therapy Monitoring
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dynamic contrast-enhanced MRI (DCE-MRI) as a measure of tumor treatment response.
Time Frame: 1 year
|
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.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jinha Park, MD, Ph.D., City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 12050
- NCI-2012-03002 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Normal Volunteers
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Repros Therapeutics Inc.Completed
-
USWM, LLC (dba US WorldMeds)National Institute on Drug Abuse (NIDA)Completed
-
Bausch Health Americas, Inc.Completed
-
USWM, LLC (dba US WorldMeds)National Institute on Drug Abuse (NIDA)Completed
-
Mayo ClinicCompleted
-
Neurovance, Inc.CompletedNormal, Healthy VolunteersAustralia