Improvements in Dynamic Contrast-Enhanced MR Angiography and Perfusion

March 15, 2024 updated by: Mayo Clinic
This study evaluates contrast-enhanced MR angiography and contrast-enhanced MR perfusion imaging for the visualization of blood vessels and enhancing tissues with better spatial detail and improved temporal fidelity compared to current methods.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To study how a variety of technological approaches in MRI can be used to provide improved performance contrast-enhanced MR imaging as used for angiography and perfusion.

OUTLINE: This is an observational study. Participants are assigned to 1 of 3 groups.

GROUP 1: Participants undergo magnetic resonance imaging (MRI) on study. Participants may also undergo blood sample collection on study.

GROUP 2: Participants receive gadolinium based MR contrast agent intravenously (IV) and undergo MRI on study. Participants may also undergo blood sample collection on study.

GROUP 3: Participants receive gadolinium based MR contrast agent IV and undergo up to two MRIs on study. Participants may also undergo blood sample collection on study.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Active, not recruiting
        • Mayo Clinic in Arizona
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
          • Clinical Trials Referral Office
          • Phone Number: 855-776-0015
        • Principal Investigator:
          • Stephen J. Riederer, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Adult male volunteers as well as Mayo patients for whom a prostate MRI exam has been clinically indicated and ordered. In some cases such as for evaluation of the vasculature of the pelvis it may be useful to extend the inclusion criteria of volunteers to adult females.

Description

Inclusion Criteria:

  • Adults

Exclusion Criteria:

  • Standard exclusion criteria for clinical MRI; e.g. cardiac pacemaker, claustrophobia, an implanted device that has been determined to be MR conditional at 1.5T but not at 3T, anticipated considerable susceptibility artifact from hip prosthesis, etc.; previous rectal surgery which may preclude tolerance of an endorectal coil

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1 (MRI)
Participants undergo MRI on study. Participants may also undergo blood sample collection on study.
Other: Non-Interventional Study
Non-interventional study
Group 2 (MRI with contrast)
Participants receive gadolinium based MR contrast agent IV and undergo a MRI on study. Participants may also undergo blood sample collection on study.
Other: Non-Interventional Study
Non-interventional study
Group 3 (MRIs with contrast)
Participants receive gadolinium based MR contrast agent IV and undergo up to two MRIs on study. Participants may also undergo blood sample collection on study.
Other: Non-Interventional Study
Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved performance in contrast-enhanced magnetic resonance imaging (MRI) as used for angiography and perfusion
Time Frame: Baseline (at enrollment); possible second scan at a later date
Assessed by comparison of two images made from the raw data set but reconstructed using the standard vs. an alternative algorithm (to be determined during study). Data will be tabulated and analyzed statistically.
Baseline (at enrollment); possible second scan at a later date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Investigators

  • Principal Investigator: Stephen J. Riederer, Ph.D., Mayo Clinic in Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2015

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

September 30, 2030

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-003511 (Other Identifier: Mayo Clinic Institutional Review Board)
  • P30CA015083 (U.S. NIH Grant/Contract)
  • NCI-2024-01895 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R01EB031790 (U.S. NIH Grant/Contract)

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.

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