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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new MRI technology to enhance imaging techniques. Participants will receive an MRI either with a contrast agent (such as Gadavist 2Ml Solution for Injection) or without it. The trial seeks both patients with scheduled MRIs and healthy volunteers who can undergo a safety check and provide consent. Those with normal kidney function and comfort in small spaces may find this trial suitable. Participants will assist researchers in evaluating the new MRI setup's performance in real-world settings. As a Phase 4 trial, this research involves FDA-approved technology and aims to understand its benefits for more patients.

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 is the safety track record for Gadavist and the investigational MRI clinical software and hardware?

Research shows that Gadavist, a dye used in MRI scans, is usually safe for most people. Serious side effects occur in only about 0.08-0.12% of patients. However, Gadavist poses risks for individuals with kidney issues, as it might lead to nephrogenic systemic fibrosis, a serious condition affecting the skin and organs.

Specific safety data on the new MRI software and equipment under testing is limited. However, MRI technology has been safely used for many years, and strict safety protocols protect patients. This trial is in a later stage, indicating that earlier tests demonstrated the technology's general safety. Participants can feel confident that the trial emphasizes safety for both new and existing technology. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Investigational MRI Technology Development trial because it aims to enhance MRI imaging using advanced software and hardware. Unlike traditional MRI techniques that rely solely on established contrast agents and existing imaging technology, this trial explores the potential of Gadavist 2Ml Solution for Injection combined with cutting-edge MRI software and hardware. This approach could lead to clearer images and more accurate diagnoses, making MRI scans more effective and efficient. By improving image quality, the trial could ultimately revolutionize how medical professionals detect and understand various conditions, offering a significant leap forward in diagnostic capabilities.

What evidence suggests that this investigational MRI technology is effective?

In this trial, participants will join different arms to evaluate the effectiveness of Gadavist and investigational MRI technology. Research has shown that Gadavist, a contrast dye used in MRI scans, effectively enhances scan clarity. It helps doctors more easily identify areas of damage and assess blood flow, aiding in the diagnosis of various conditions. Studies involving over 23,000 patients have demonstrated its effectiveness, particularly in detecting tumors and other issues. Gadavist has been used safely for over 25 years in people of all ages and with various health conditions.

Regarding the new MRI software and hardware tested in this trial, recent improvements in MRI technology focus on enhancing scan clarity and reducing image noise. These new methods, including advanced computer techniques, aim to provide more detailed and clearer MRI images. While the specific technology in this trial remains under study, these innovations are designed to offer better diagnostic information through improved imaging. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6153968/

Gadobutrol: A Review in Contrast-Enhanced MRI and MRA Gadobutrol represents an effective and safe diagnostic GBCA for use in CE MRI and MRA to visualize pathological lesions and vascular perfusion and flow-related ...

2. journals.lww.com journals.lww.com/investigativeradiology/fulltext/2024/05000/clinical_efficacy_of_gadobutrol__review_of_over_25.1.aspx

Clinical Efficacy of Gadobutrol: Review of Over 25 Years ... Gadobutrol is an efficacious magnetic resonance imaging contrast agent for all age groups in various approved indications throughout the whole body.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00468819

A Study of Magnetic Resonance Imaging (MRI) With ... The company Bayer HealthCare Pharmaceuticals has developed a contrast agent for MRI called Gadavist 1.0 which was first approved in 1998 in Switzerland for MRI ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00623467?tab=table

Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in ... The data for contrast enhancement - gadobutrol combined was shown below. Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5127858/

Safety of gadobutrol in over 23000 patients - PubMed Central The majority of MRI scans in the 23,697 patients in the efficacy population were for suspected tumours (54.4 %), followed by infarction (9.0 %), inflammatory ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2011/201277s000lbl.pdf

Gadavist (gadobutrol) injection - accessdata.fda.gov Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid ...

7. radiologysolutions.bayer.com radiologysolutions.bayer.com/products/contrast-agents/gadavist-injection

Gadavist (gadobutrol) injection Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures.

8. mayoclinic.org mayoclinic.org/drugs-supplements/gadobutrol-intravenous-route/description/drg-20074828

Gadobutrol (intravenous route) - Side effects & uses Gadobutrol injection is a magnetic resonance imaging (MRI) contrast agent ... However, safety and efficacy have not been established in ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21623211/

Safety of gadobutrol, a new generation of contrast agents Gadobutrol was well tolerated by adults, by children, by patients with impaired liver or kidney function, and by patients with cardiovascular disease. The ...

10. scmr.site-ym.com scmr.site-ym.com/?page=ContrastAgentSafety

Gadolinium Contrast Agent Safety and Significance of Recent ... In the last 29 years, over 100 million patients have received GBCA with an excellent safety profile (incidence of acute reaction ranging from 0.08-0.12%).