Low-Dose Gadobutrol + AI for Brain Tumor Imaging

No longer recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Subtle Medical

Disqualifiers: Multiple sclerosis, Severe cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to create clearer MRI images of brain tumors using a lower dose of gadobutrol, a contrast dye, combined with AI technology. The goal is to determine if these images match the quality of those taken with the usual higher dose. Participants will receive varying doses of gadobutrol in two stages to compare results. Individuals with known or suspected brain tumors, who do not have conditions like multiple sclerosis or severe heart disease, might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to experience this innovative approach.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are expected to have a change in treatment that may affect the study, you may not be eligible to participate.

What prior data suggests that this software medical device and low-dose gadobutrol are safe for brain tumor imaging?

Research shows that gadobutrol, the contrast agent being tested, is very safe. It has been used over 100 million times worldwide, demonstrating a strong safety record. Most studies focus on the usual dose of gadobutrol, 0.1 mmol/kg, and even at this full dose, most patients tolerate it well.

This clinical trial tests much lower doses of gadobutrol, such as 0.01 mmol/kg and 0.025 mmol/kg. These smaller doses suggest even greater safety, as lower doses often result in fewer side effects. The trial examines whether these reduced doses, combined with AI technology, can still produce clear MRI images.

Overall, gadobutrol is a well-known and trusted contrast agent, which supports confidence in its safety, even at these new, lower doses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using low-dose gadobutrol combined with AI for brain tumor imaging because it offers a potentially safer and more efficient alternative to standard MRI contrast agents. Unlike traditional protocols that use higher doses of gadobutrol, this approach utilizes significantly lower doses (10% and 25% of the standard dose), which could reduce the risk of side effects while still providing clear imaging. Additionally, the integration of AI technology, like SubtleGAD, aims to enhance image quality and accuracy, possibly leading to better diagnosis and treatment planning for patients with brain tumors.

What evidence suggests that this trial's treatments could be effective for brain tumor imaging?

Research has shown that gadobutrol effectively improves MRI images, particularly for detecting brain lesions. One study found that a standard dose of gadobutrol (0.1 mmol/kg) can clearly reveal brain metastases with just one injection. In this trial, participants in Group A will receive a 10% dose of gadobutrol, while those in Group B will receive a 25% dose. Other studies suggest that even lower doses of similar agents can maintain effectiveness. The AI software, SubtleGAD, enhances the quality of these low-dose images, making it easier to see important details. This approach aims to maintain high image quality while using less gadobutrol, potentially increasing patient safety. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with known or highly suspected brain tumors. Participants must be suitable for MRI scans and contrast agents. Specific eligibility criteria are not provided, but typically include age, health status, and tumor characteristics.

Inclusion Criteria

I understand the study details and agree to participate.

Have known or highly suspected brain lesions referred for contrast-enhanced MRI of the CNS.

Have an estimated glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m^2.

Exclusion Criteria

Considered clinically unstable or has a concomitant/intercurrent condition that would not allow participation in the study.

I have severe heart disease.

I have a diagnosis like multiple sclerosis that changes over time.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment Period 1

Participants receive a standard dose gadobutrol (0.1 mmol/kg) for contrast-enhanced MRI

1 day

1 visit (in-person)

Washout

A washout period of at least 72 hours but less than 15 days between treatment periods

3-15 days

Treatment Period 2

Participants receive a low dose gadobutrol (0.01 mmol/kg or 0.025 mmol/kg) for contrast-enhanced MRI

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Gadobutrol
• SubtleGAD

Trial Overview The study is testing if low doses of a contrast agent called Gadobutrol enhanced by AI software (SubtleGAD) can produce MR images as clear as those taken with standard higher doses. It's a randomized test comparing two different low-dose groups against the standard dose.

How Is the Trial Designed?

Group I: Group A (10% dose GV) Active Control 2 Interventions

Each participant will receive a Standard dose gadobutrol (0.1 mmol/kg) in Period 1 and 10% dose gadobutrol (0.01 mmol/kg) in Period 2. During study Period 1, each participant will receive gadobutrol as a single intravenous (IV) administration at the standard dose for contrast-enhanced MRI followed by study Period 2 where a single IV low dose (10% dose) of gadobutrol will be administered. There will be a washout period of at least 72 hours but less than 15 days between the two periods. The individual study duration will therefore range from 4 to 15 days.

Group II: Group B (25% dose GV) Active Control 2 Interventions

Each participant will receive a Standard dose gadobutrol (0.1 mmol/kg) in Period 1 and Study Period 2: 25% dose gadobutrol (0.025 mmol/kg) in Period 2. During study Period 1, each participant will receive gadobutrol as a single intravenous (IV) administration at the standard dose for contrast-enhanced MRI followed by study Period 2 where a single IV low dose (25% dose) of gadobutrol will be administered. There will be a washout period of at least 72 hours but less than 15 days between the two periods. The individual study duration will therefore range from 4 to 15 days.

Who Is Running the Clinical Trial?

Subtle Medical

Lead Sponsor

Trials

1

Recruited

60+

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9575215/

Time optimization of gadobutrol-enhanced brain MRI for ... Conclusions. Maximum contrast enhancement and lesion conspicuity was achieved 5–7 min after a single gadobutrol injection for brain metastases detection and ...

3. ajronline.org ajronline.org/doi/10.2214/AJR.09.3427?doi=10.2214/AJR.09.3427

Brain MRI With Single-Dose (0.1 mmol/kg) Gadobutrol at 1.5 T ... This study shows that the application of gadobutrol (0.1 mmol/kg of body weight) is as effective as a 1.5-fold dose of gadoterate meglumine (0.15 mmol/kg of ...

4. kjronline.org kjronline.org/DOIx.php?id=10.3348/kjr.2014.15.1.145

Effect of Imaging Time in the Magnetic Resonance ... Both 1-minute and 5-minute-delayed imaging after gadobutrol injection appears to be effective for the detection of intracerebral metastases.

5. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.222612

Efficacy and Safety of Half-Dose Gadopiclenol versus Full- ... Gadopiclenol at half the standard dose for contrast-enhanced body MRI had comparable efficacy with gadobutrol at the full standard dose.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4089836/

Safety and Efficacy of Gadobutrol-Enhanced MRI in Patients ... This study indicates that gadobutrol at a standard dose for MRI is safe in patients aged < 2 years and provides diagnostic information for multiple pathologies.

7. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/g/gadovistinj.pdf

GADOVIST® 1.0 (1.0 mmol/mL) Solution for Intravenous ... Reduced dosing in CNS imaging. In a study designed as an intra-individual, non-randomised, crossover comparison, gadobutrol at a reduced dose of 0.075 mmol/kg ...

8. journals.lww.com journals.lww.com/investigativeradiology/fulltext/2024/09000/clinical_safety_of_gadobutrol__review_of_over_25.1.aspx

Clinical Safety of Gadobutrol: Review of Over 25 Years of... Over the last 25 years, gadobutrol has been administered more than 100 million times worldwide providing a wealth of data related to safety.

9. fda.gov fda.gov/media/80580/download

201277 Gadobutrol Clinical PREA For diagnostic magnetic resonance imaging; Gadobutrol Injection is a gadolinium- ... Accuracy comparison of the low-standard gadobutrol dose ...