Improvements in Dynamic Contrast-Enhanced MR Angiography and Perfusion

Prostate Neoplasm Clinical Trial

Official title:

Improvements in Dynamic Contrast-Enhanced MR Angiography and Perfusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06315595
• Other study ID #: 15-003511
• Secondary ID: NCI-2024-0189515
• Status: Recruiting
• Start date: September 30, 2015
• Est. completion date: September 30, 2030

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 30, 2030
• Est. primary completion date: September 30, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

Other:
• Non-Interventional Study
Non-interventional study

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI), National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved performance in contrast-enhanced magnetic resonance imaging (MRI) as used for angiography and perfusion	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