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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01752231
First received: December 12, 2012
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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 Intervention
Normal Volunteers
Drug: MultiHance
Procedure: dynamic contrast-enhanced magnetic resonance imaging

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: MultiHance
Other Name: Gadobenate dimeglumine
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Undergo DCE-MRI using new pulse sequences
Other Name: DCE-MRI

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752231

Locations
United States, California
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
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01752231     History of Changes
Other Study ID Numbers: 12050, NCI-2012-03002
Study First Received: December 12, 2012
Last Updated: July 31, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gadolinium DTPA
Gadobenic acid
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014