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Active, not recruiting

NCT Number: NCT05215132

Investigational MRI Clinical Software and Hardware

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

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Image, Body

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern University- Feinberg School of Medicine

Chicago, Illinois, 60611, United States

About this study

The aims of this study are to:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Radiation

1.5T or 3T MRI scanner (Siemens Medical Systems)

Gadavist 2Ml Solution for Injection

Drug

Arm 1 and Arm 3 subjects will undergo this intervention (Gadavist 2Ml solution)

Primary outcomes

  1. Conduct clinical protocol development and validation

    Time frame: 5 years

    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.

Secondary outcomes

  1. Demonstrate and train

    Time frame: 5 years

    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.

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

Notify Me

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Study Evaluation of Feasibility and Reproducibility of Investigational MRI Clinical Software

Acronym: Avery HS

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Jan 31, 2022
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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