Optimization of Novel DCE-MRI Imaging Sequences for Cancer Therapy Monitoring
NCT ID: NCT01752231
Last Updated: 2017-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
1 participants
OBSERVATIONAL
2013-07-23
2017-08-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
100 Years
ALL
Yes
Sponsors
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City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jinha Park, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2012-03002
Identifier Type: REGISTRY
Identifier Source: secondary_id
12050
Identifier Type: -
Identifier Source: org_study_id