Investigational MRI Technology Development

(Avery HS Trial)

Recruiting at 1 trial location

Overseen By Ryan Avery

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Northwestern University

Disqualifiers: GFR < 30, Acute kidney injury, Allergy to gadolinium, MRI contraindication, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

2000 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug Gadavist (gadobutrol) in MRI technology development?

Gadobutrol, known as Gadavist, is a highly concentrated contrast agent used in MRI scans to improve image clarity, and it has been shown to be effective in enhancing the visibility of lesions and blood flow in various body regions. It is well-tolerated across a wide range of patients, including children and those with kidney or liver issues, and has a lower risk of causing nephrogenic systemic fibrosis compared to other similar agents. ^{1 2 3 4 5}

How does the drug gadobutrol differ from other treatments for MRI imaging?

Gadobutrol is unique because it is formulated at twice the gadolinium ion concentration of other gadolinium-based contrast agents, which reduces the injection volume and improves image enhancement during MRI scans. This higher concentration also contributes to its effectiveness in detecting conditions like prostate cancer with greater accuracy. ^{1 2 3 5 6}

Eligibility Criteria

This trial is for adults over 18 who can complete an MR safety questionnaire and consent in English. Participants must have a certain level of kidney function, with patients requiring a GFR ≥30 ml/min and healthy volunteers needing a GFR≥60 ml/min. It excludes prisoners, those with acute kidney issues or allergies to gadolinium contrast media, pregnant or breastfeeding women, and anyone unable to undergo MRI.

Inclusion Criteria

Able to comprehend and provide informed consent in English

My kidney function is good, with a GFR of 60 ml/min or higher.

Able to complete the MR safety questionnaire

Exclusion Criteria

I am allergic to gadolinium-based contrast agents.

I have a recent kidney injury and need a contrast agent for my test.

My kidney function is low (GFR < 30 ml/min) and I need contrast for a test.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Clinical Protocol Development and Validation

Testing of new MRI pulse sequences for validation of potential new diagnostic capabilities

5 years

1 visit (in-person) per participant

Demonstration and Training

Human subjects scanned for demonstrating equipment or training operators on MRI systems

5 years

1 visit (in-person) per participant

Follow-up

Participants are monitored for safety and effectiveness after MRI procedures

4 weeks

Treatment Details

Interventions

• Gadavist 2Ml Solution for Injection
• Investigational MRI Clinical Software and Hardware

Trial Overview The study is testing new software and hardware sequences for MRI scans on both patients with Body Dysmorphic Disorder and healthy volunteers. Some participants will receive an injection of Gadavist contrast agent during their scan.

Participant Groups

Group I: Volunteer w/ contrast Experimental Treatment 2 Interventions

Volunteers undergo 1 research MRI for research purposes

Group II: Volunteer no contrast Experimental Treatment 1 Intervention

Volunteers undergo 1 research MRI for research purposes

Group III: Patient w/ Contrast Experimental Treatment 2 Interventions

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

Group IV: Patient no contrast Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

In a study involving 229 adult patients with suspected brain tumors, gadobutrol and gadoteridol were found to provide similar effectiveness in enhancing MR imaging for lesion detection and characterization, despite gadobutrol being at a higher concentration.

There were no significant differences in adverse events between the two contrast agents, indicating that both are safe options for patients undergoing brain imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are there differences between macrocyclic gadolinium contrast agents for brain tumor imaging? Results of a multicenter intraindividual crossover comparison of gadobutrol with gadoteridol (the TRUTH study). Maravilla, KR., Smith, MP., Vymazal, J., et al.[2021]

Gadobutrol, a second-generation gadolinium-based contrast agent, is effective for enhancing MRI images across various medical fields, allowing for better visualization of pathological lesions and improved diagnostic capabilities.

It is generally well tolerated in a wide range of patients, including those with renal or hepatic impairments, and has a lower risk of causing nephrogenic systemic fibrosis compared to older linear GBCAs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gadobutrol: a review of its use for contrast-enhanced magnetic resonance imaging in adults and children. Scott, LJ.[2021]

Gadobutrol, a gadolinium-based contrast agent, demonstrated a high safety margin in preclinical studies, with no adverse effects observed at doses 10 to 12 times higher than the standard diagnostic dose used in humans (0.1 mmol/kg).

The compound was well tolerated in animal studies, showing no teratogenic effects and no indications of genotoxicity or immunotoxicity, making it a safe option for use in magnetic resonance imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicological safety evaluation of gadobutrol. Wack, C., Steger-Hartmann, T., Mylecraine, L., et al.[2019]

Gadobutrol, a macrocyclic contrast agent, has an excellent safety profile, with only 4.0% of patients experiencing adverse events in clinical trials, comparable to other contrast agents.

The safety of gadobutrol was confirmed across various patient populations, including children and those with renal or hepatic impairments, with serious adverse reactions being very rare in over 5.7 million administrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of gadobutrol, a new generation of contrast agents: experience from clinical trials and postmarketing surveillance. Voth, M., Rosenberg, M., Breuer, J.[2014]

Gadobutrol is a safe and effective gadolinium-based contrast agent for MRI, with over 20 years of clinical experience and more than 50 million doses administered, showing a low risk of nephrogenic systemic fibrosis (NSF).

Its unique formulation, with a higher gadolinium ion concentration, allows for improved image enhancement during diagnostic procedures, making it suitable for a wide range of patients, including those with renal or hepatic impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gadobutrol: A Review in Contrast-Enhanced MRI and MRA. Scott, LJ.[2022]

In a study involving 379 patients, the use of 1 M gadobutrol as a contrast agent in multiparametric MRI significantly improved the accuracy and specificity of prostate cancer detection compared to 0.5 M gadoterate meglumine or gadopentetate dimeglumine.

While gadobutrol enhanced accuracy, it did not show significant differences in sensitivity or predictive values, suggesting it is particularly effective for confirming cancer presence rather than detecting it in all cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate Cancer Detection with Multiparametric MRI: A Comparison of 1 M-Concentration Gadobutrol with 0.5 M-Concentration Gadolinium-Based Contrast Agents. Hara, T., Ogata, T., Wada, H., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Are there differences between macrocyclic gadolinium contrast agents for brain tumor imaging? Results of a multicenter intraindividual crossover comparison of gadobutrol with gadoteridol (the TRUTH study). [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Gadobutrol: a review of its use for contrast-enhanced magnetic resonance imaging in adults and children. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Toxicological safety evaluation of gadobutrol. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Safety of gadobutrol, a new generation of contrast agents: experience from clinical trials and postmarketing surveillance. [2014]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Gadobutrol: A Review in Contrast-Enhanced MRI and MRA. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Prostate Cancer Detection with Multiparametric MRI: A Comparison of 1 M-Concentration Gadobutrol with 0.5 M-Concentration Gadolinium-Based Contrast Agents. [2022]