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

Sponsor
City of Hope Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT01752231
Collaborator
(none)
1
Enrollment
1
Location
49.2
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This pilot clinical trial studies dynamic contrast enhanced (DCE)-magnetic resonance imaging (MRI) in diagnosing cancer. New diagnostic procedures, such as DCE-MRI may help find and diagnose cancer

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    PRIMARY OBJECTIVES:

    1. 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.

    2. Determine the ideal radiofrequency (RF) coil setup to maximize signal to noise ratio of the optimized pulse sequences.

    3. 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.

    4. 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 Design

    Study Type:
    Observational
    Actual Enrollment :
    1 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Optimization of Novel DCE-MRI Imaging Sequences for Cancer Therapy Monitoring
    Actual Study Start Date :
    Jul 23, 2013
    Actual Primary Completion Date :
    Aug 29, 2017
    Actual Study Completion Date :
    Aug 29, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Dynamic contrast-enhanced MRI (DCE-MRI) as a measure of tumor treatment response. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010

    Sponsors and Collaborators

    • City of Hope Medical Center

    Investigators

    • Principal Investigator: Jinha Park, MD, Ph.D., City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT01752231
    Other Study ID Numbers:
    • 12050
    • NCI-2012-03002
    First Posted:
    Dec 19, 2012
    Last Update Posted:
    Dec 21, 2017
    Last Verified:
    Dec 1, 2017

    Study Results

    No Results Posted as of Dec 21, 2017