Investigational MRI Clinical Software and Hardware (Avery HS)

Northwestern University

Status and phase: Enrolling; Phase 4

Conditions: Image, Body

Treatments: Drug: Gadavist 2Ml Solution for Injection; Radiation: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT05215132

STU#00211312

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,000 participants in 4 patient groups

Patient w/ Contrast

Other group

Description:

Patients will add 15 minutes to their SOC MRI for research purposes

Treatment:

Radiation: MRI

Drug: Gadavist 2Ml Solution for Injection

Patient no contrast

Other group

Description:

Patients will add 15 minutes to their SOC MRI for research purposes

Treatment:

Radiation: MRI

Volunteer w/ contrast

Other group

Description:

Volunteers undergo 1 research MRI for research purposes

Treatment:

Radiation: MRI

Drug: Gadavist 2Ml Solution for Injection

Volunteer no contrast

Other group

Description:

Volunteers undergo 1 research MRI for research purposes

Treatment:

Radiation: MRI