Investigational MRI Clinical Software and Hardware

Image, Body Clinical Trial

— Avery HS  

Official title:

Study Evaluation of Feasibility and Reproducibility of Investigational MRI Clinical Software

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05215132
• Other study ID #: STU#00211312
• Status: Recruiting
• Phase: Phase 4
• Start date: December 19, 2019
• Est. completion date: January 31, 2025

Study information

• Verified date: November 2023
• Source: Northwestern University
• Contact: Emily Powell
• Phone: 312.695.2956
• Email: emily.powell[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients and healthy volunteers will be scanned in order to test new sequences.

Description:

The aims of this study are to:

1. Conduct clinical protocol development and validation: The settings of an MRI machine are commonly adjusted according to the body part being scanned and the reason for the exam. When testing out new sequences and settings or adjusting existing settings, human subjects (patients and healthy volunteers) may be scanned in order to make sure that the quality of the images produced by the MRI machine is adequate for diagnostic purposes and to obtain normative values.

2. Demonstrate and train: In some cases, human subjects may be scanned for the purposes of demonstrating equipment or for training operators on the safe and effective use of MRI systems.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• • At least 18 years of age

• Able to complete the MR safety questionnaire.

• Able to comprehend and provide informed consent in English.

• When contrast is being administered: healthy volunteers with a GFR=60 ml/min

• When contrast is being administered: patients with a GFR =30 ml/min

Exclusion Criteria:

• • When contrast is being administered: subjects with a GFR < 30 ml/min

• When contrast is being administered: subjects with acute kidney injury

• When contrast is administered, allergy to gadolinium-containing contrast media

• Contraindication to MRI (implanted device, claustrophobia, dyspnea precluding the ability to follow breath-hold instructions)

• Adults unable to consent

• Individuals who are not yet adults

• Pregnant or breastfeeding women

• Prisoners

Related Conditions & MeSH terms

• Image, Body

Intervention

Radiation:
• MRI
1.5T or 3T MRI scanner (Siemens Medical Systems)

Drug:
• Gadavist 2Ml Solution for Injection
Arm 1 and Arm 3 subjects will undergo this intervention (Gadavist 2Ml solution)

Locations

Country	Name	City	State
United States	Northwestern University- Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conduct clinical protocol development and validation	Testing of new MRI pulse sequences will be performed for validation of potential new diagnostic capabilities. The MRI pulse sequences will be routinely performed along with clinically-validated and accepted pulse sequences for comparison of the novel sequences in human subjects (patients and healthy volunteers). Novel sequences will be performed in the accepted method with adjustment of settings to evaluate image qualities and normative values produced by the MRI machine. The resulting images provided by the novel sequences will be able to evaluated for diagnostic quality and to obtain comparison of possible improvements alongside clinically-validated MRI pulse sequences.	5 years
Secondary	Demonstrate and train	Human subjects may be scanned utilizing MRI pulse sequences in the context of a clinical assessment for demonstrating of equipment or sequence function for training of MRI technologist. The sequence will be performed by a skilled technologist with the primary goal of providing information on proper utilizing of MRI hardware and software for technologist who are training and will be possibly utilizing these technique to provided safe and effective use of MRI systems and their software.	5 years