What side effects are associated with this type of intervention?

The most common side effects of MRI contrast agents such as Dotarem and Gadavist include headache, nausea, dizziness, and injection site reactions. Rare but serious side effects can include allergic reactions, which may manifest as rash, itching, or difficulty breathing. It is important for patients to discuss any history of allergies or kidney issues with their doctor before undergoing an MRI with contrast.

What prior FDA approvals exist?

Dotarem (gadoterate meglumine) and Gadavist (gadobutrol) are FDA-approved MRI contrast agents used to enhance the visualization of breast lesions. These agents improve the diagnostic accuracy of breast MRI by providing better contrast between normal and abnormal tissues. Both agents are gadolinium-based and are used to help detect and characterize breast cancer and other breast diseases. Their approval has provided clinicians with valuable tools for the early detection and accurate diagnosis of breast conditions.

What other types of research exist?

A promising novel alternative to Dotarem and Gadavist for breast disease patients is the Lumazine Synthase Protein Nanoparticle-Gd(III)-DOTA Conjugate, which has shown potential as a T1 contrast agent for high-field MRI.

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Dotarem vs Gadobutrol Contrast for Breast Cancer Imaging

Phase 4

Recruiting

Led By Nicholas Bloch, MD

Research Sponsored by University of Massachusetts, Worcester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Pre Menopause women outside of the 7-14 days from cycle

Have already begun therapeutic treatment for breast cancer including surgery (lumpectomy or mastectomy), radiotherapy, or chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial compares two MRI contrast agents, Dotarem and Gadavist, in women mostly diagnosed with breast cancer. These dyes help make MRI images clearer, aiding doctors in diagnosing breast lesions.

Who is the study for?

This trial is for women aged 18 or older who need a breast MRI with contrast and have had, or will likely have, a tissue sampling of the breast. It's not for pregnant women, those already treated for breast cancer, or premenopausal women outside of days 7-14 of their cycle.

What is being tested?

The study compares two MRI contrast agents: Dotarem (Gadoterate meglumine) and Gadavist (Gadobutrol). Participants are randomly chosen to receive one of these agents to see if Dotarem is as effective in highlighting breast lesions as Gadavist.

What are the potential side effects?

Potential side effects from both contrast agents may include allergic reactions, headache, nausea, dizziness, cold sensations at the injection site. These are generally mild but can vary among individuals.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a premenopausal woman not within 7-14 days of my menstrual cycle.

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I have started treatment for breast cancer, including surgery, radiotherapy, or chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of breast MRI

Secondary study objectives

Maximum enhancement slope for contrast breast MRI

Maximum relative enhancement (E(max) for contrast breast MRI

Time to peak enhancement (T(max)) for contrast breast MRI

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Gadobutrol contrastExperimental Treatment1 Intervention

0.1 mL/kg (0.1 mmol/kg) administered as a single IV bolus injection by power injector. Imaging may begin after administration and then repeat sequentially to determine peak intensity and wash-out. The manufacturer provides weight-based dose volumes as follow: 35 kg: 3.5 mL; 40 kg: 4 mL; 45 kg: 4.5 mL; 50 kg: 5 mL; 60 kg: 6 mL; 70 kg: 7 mL; 80 kg: 8 mL; 90 kg: 9 mL; 100 kg: 10 mL; 110 kg: 11 mL; 120 kg: 12 mL; 130 kg: 13 mL; 140 kg: 14 mL.

Group II: Gadoterate meglumine contrastActive Control1 Intervention

0.2 mL/kg (0.1 mmol/kg) administered as a single IV bolus injection at a rate of 2 mL/second. The FDA-approved product labeling provides weight-adjusted dose volumes as follows: 30 kg: 6 mL; 40 kg: 8 mL; 50 kg: 10 mL; 60 kg: 12 mL; 70 kg: 14 mL; 80 kg: 16 mL; 90 kg: 18 mL; 100 kg: 20 mL; 110 kg: 22 mL; 120 kg: 24 mL; 130 kg: 26 mL; 140 kg: 28 mL; 150 kg: 30 mL.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gadobutrol

2020

Completed Phase 3

~960

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

MRI contrast agents like Dotarem and Gadavist work by enhancing the visibility of breast lesions during imaging. These agents contain gadolinium, a rare earth metal, which alters the magnetic properties of nearby water molecules, thereby improving the contrast of the images. This enhanced imaging is crucial for accurately diagnosing and characterizing breast lesions, distinguishing between benign and malignant tissues, and guiding biopsy and treatment decisions. For breast disease patients, the use of effective contrast agents can lead to earlier and more precise detection, which is essential for successful treatment outcomes.

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