AI-Assisted Low-Dose Gadolinium Breast MRI for Breast Cancer

Overseen By Quenteeria Mooney, BS

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: University of Alabama at Birmingham

Disqualifiers: Non-female, Pregnant, Recurrent cancer, 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 of using MRI scans to examine breast cancer. Researchers aim to determine if a smaller amount of gadolinium, enhanced by artificial intelligence (AI), can still accurately differentiate between harmless and dangerous breast lumps. The goal is to reduce the gadolinium dose, potentially benefiting brain health, and to improve doctors' ability to detect breast issues. The trial seeks women newly diagnosed with breast cancer or those requiring an MRI for non-cancer reasons who have had a noticeable mass or area in a previous exam. 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this AI-assisted low-dose gadolinium breast MRI is safe?

Research has shown that using a lower dose of gadolinium in breast MRIs can be safer for patients. In one study with 104 women, reducing the gadolinium dose by 75% still provided clear images. This reduction could lead to fewer side effects while maintaining scan accuracy.

Gadolinium, a substance used in MRI scans, enhances tissue visibility. While effective, it can sometimes cause allergic reactions and, in rare cases, a serious condition affecting the skin and organs, particularly in individuals with kidney issues. Reducing gadolinium aims to lower these risks.

Additionally, AI technology can enhance the clarity of these low-dose images. This ensures doctors receive the detailed pictures needed to detect cancer. Using AI can make the procedure safer by reducing the required gadolinium amount. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the AI-assisted low-dose gadolinium breast MRI technique because it aims to enhance imaging precision while using a significantly lower dose of gadolinium contrast compared to traditional methods. This could reduce potential side effects associated with gadolinium, which is a concern in standard MRIs. Additionally, by integrating artificial intelligence, this approach promises quicker and potentially more accurate detection of breast lesions, which could lead to earlier and more effective treatment decisions.

What evidence suggests that AI-assisted low-dose gadolinium breast MRI is effective for breast cancer?

This trial will compare AI-assisted low-dose gadolinium breast MRI with the standard gadolinium breast MRI. Research has shown that AI can provide accurate results even with reduced gadolinium in breast MRI scans. One study found that AI can recreate the full details of the scan with less gadolinium. This capability may help doctors better distinguish between non-cancerous and cancerous breast lumps. Reducing gadolinium is important because it decreases the amount retained in the brain, addressing a safety concern. Overall, this AI-assisted method could enhance the effectiveness of breast cancer screenings in correctly identifying issues. ^{1 2 3 4 5}

Who Is on the Research Team?

Stefanie Woodard, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for women aged 18-99 who need a breast MRI, either because they're being screened or have known breast lesions. It's open to those with new primary breast cancer but not recurrent cases. Participants must be able to lie still for an hour and can't join if pregnant, breastfeeding, under 18, have had neoadjuvant chemotherapy, or can't undergo MRI.

Inclusion Criteria

I am referred for an MRI for reasons not related to cancer.

You have had a previous exam that showed abnormal growth or changes in your body.

I am willing and able to join the trial.

Exclusion Criteria

I am not female.

I cannot stay still for an hour on an imaging table.

I am currently pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial MRI Exam

Participants undergo an initial MRI with a regular dose of gadolinium

1 week

1 visit (in-person)

Reduced Dose MRI Exam

Participants undergo a second MRI with a ¼ dose of gadolinium at least 14 days after the initial exam

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after MRI exams

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Reduced Dose Gadolinium Breast MRI with AI
• Standard of Care Gadolinium Breast MRI

Trial Overview The study compares two types of breast MRIs: one uses a quarter dose of gadolinium contrast with AI assistance; the other is the standard full-dose MRI without AI. The goal is to see if AI can help diagnose benign and malignant lesions accurately even with less contrast agent.

How Is the Trial Designed?

Group I: Subjects with enhancing breast lesions Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Bracco Corporate

Industry Sponsor

Trials

7

Recruited

580+

Published Research Related to This Trial

In a study of 45 breast cancer patients and 35 benign tumor patients, key MRI indicators for diagnosing breast cancer were identified, including tumor edge features, time-signal intensity curve (TIC) types, and apparent diffusion coefficient (ADC) values at b=500 s/mm2.

The combination of conventional MRI, diffusion-weighted imaging (DWI), and dynamic contrast-enhanced MRI provided the best diagnostic approach, with magnetic resonance spectroscopy (MRS) serving as a useful supplementary tool for challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Optimization of diagnosis indicator selection and inspection plan by 3.0T MRI in breast cancer]. Jiang, Z., Wang, Y., He, Z., et al.[2015]

Citations

1. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.222211

Using Machine Learning to Reduce the Need for Contrast ... Generative adversarial networks can help recover the full contrast information from simulated low-dose contrast-enhanced breast MRI examinations.

2. withpower.com withpower.com/trial/phase-1-breast-neoplasms-11-2021-c2de9

AI-Assisted Low-Dose Gadolinium Breast MRI for ... The purpose of this study is to evaluate the ability of AI to correctly aid in characterization of benign and malignant lesions even when a low dose of ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899707125000208

A review of gadolinium-based contrast agents in the setting ... We will specifically review the difference between the two most commonly used contrast agents, gadobutrol (Gadavist, Bayer Schering Pharma) and gadoterate ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10140636/

The Quest to Reduce the Use of Gadolinium-based ... Another approach is to reduce the dose of GBCAs. In fact, a prospective study of 104 women found that a reduced dose (75%) of gadobenate ...

5. ajronline.org ajronline.org/doi/10.2214/AJR.19.21988

Gadolinium Retention and Breast MRI Screening: More Harm ... Breast MRI was associated with a significantly higher cancer detection rate (odds ratio [OR], 1.7) and biopsy rate (OR, 2.2) than was mammography alone. However ...