Dotarem vs Gadobutrol Contrast for Breast Cancer Imaging

Overseen By Nicolas Bloch, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Pregnancy, Breast cancer treatment, 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: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates two MRI contrast agents, Dotarem and Gadobutrol, to determine if they enhance breast cancer images similarly. Researchers aim to assess whether Dotarem is as effective as Gadobutrol in revealing breast lesions. Women scheduled for a breast MRI with contrast, who may also have a tissue sample taken for testing, are suitable candidates for this study. Participants will be randomly assigned to receive one of the two contrast agents. The trial's goal is to compare the image quality and diagnostic value of each agent. As a Phase 4 trial, it involves FDA-approved treatments and seeks to understand how they can benefit 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. It is best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that Dotarem and Gadobutrol, both used as MRI contrast agents, are very safe. A study involving over 35,000 patients found that Dotarem, also known as gadoterate meglumine, was safe and generally well-tolerated, with most side effects being mild. Another review of its 35-year use also supported its safety for imaging.

For Gadobutrol, studies have confirmed its safety and effectiveness, even in young children. The most common side effects are headaches and nausea, but these are rare, affecting less than 2% of people. Both contrast agents have been widely used, and their safety in humans is well-established. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the use of Dotarem and Gadobutrol for breast cancer imaging because these contrast agents offer unique features that could enhance diagnostic accuracy. Unlike standard MRI contrast agents, Dotarem utilizes gadoterate meglumine, which is known for its safety profile and stability. Gadobutrol, on the other hand, is distinguished by its higher concentration, allowing for potentially clearer and more detailed images. These differences may lead to more precise imaging, which can help in better detection and characterization of breast cancer.

What evidence suggests that this trial's treatments could be effective for breast cancer imaging?

This trial will compare Dotarem and Gadobutrol as contrast agents for MRI scans in breast cancer imaging. Research has shown that both Dotarem and Gadobutrol are effective. Studies have found that Dotarem helps radiologists clearly see breast lesions, aiding in early detection and detailed imaging, with detection rates for lesions between 84.5% and 90.8%. In contrast, Gadobutrol has proven effective in detecting all known breast cancers in MRI scans, even those as small as 0.4 cm. Both agents offer similar safety and effectiveness, making them reliable choices for breast imaging. ^{2 4 6 7 8}

Who Is on the Research Team?

Nicholas Bloch, MD

Principal Investigator

UMASS Medical School

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a woman aged 18 or older.

I am scheduled for a contrast MRI of the breast.

I have had, or will have, a breast tissue exam with results available within 6 months of my MRI.

Exclusion Criteria

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

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

Pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single IV bolus injection of either Gadoterate meglumine or Gadobutrol contrast agent, followed by MRI imaging

1 day

1 visit (in-person)

Image Analysis

MRI images are analyzed for contrast enhancement quality by blinded radiologists and software

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Dotarem
• Gadobutrol

Trial Overview

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.

How Is the Trial Designed?

Group I: Gadobutrol contrast Experimental Treatment 1 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 contrast Active Control 1 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.

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Guerbet

Industry Sponsor

Trials

72

Recruited

94,600+

David Hale

Guerbet

Chief Executive Officer since 2020

MBA from IMD

Philippe Bourrinet

Guerbet

Chief Medical Officer since 2023

MD

Published Research Related to This Trial

In a study of 51 postmenopausal women with locally advanced breast cancer, 40% responded positively to Nolvadex (Tamoxifen), with 75% of those responders remaining in remission for a median of 36 months.

For patients who did not respond to Nolvadex, radiotherapy was effective in achieving local control in 64% of cases, providing a median duration of 10 months, indicating a satisfactory management option for non-responders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The management of locally advanced carcinoma of the breast by Nolvadex (tamoxifen): a pilot study. Campbell, FC., Morgan, DA., Bishop, HM., et al.[2013]

In a follow-up study of 222 post-operative premenopausal patients with endocrine-responsive breast cancer, leuprorelin treatment for 3 years showed no significant improvement in disease-free survival compared to 2 years, indicating similar efficacy for both durations.

However, in a small subgroup of higher-risk patients, those receiving leuprorelin for 3 years had a significantly longer disease-free survival, suggesting that longer treatment may benefit specific patients without introducing new safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A follow-up study of a randomized controlled study evaluating safety and efficacy of leuprorelin acetate every-3-month depot for 2 versus 3 or more years with tamoxifen for 5 years as adjuvant treatment in premenopausal patients with endocrine-responsive breast cancer. Kurebayashi, J., Shiba, E., Toyama, T., et al.[2021]

Leuprorelin acetate 6-month depot is more cost-effective than the 3-month depot for pre-menopausal breast cancer patients, saving a total of JPY 66,032 per patient by reducing the number of injections needed.

The savings come from reduced medical costs, productivity losses, and significant intangible costs related to pain and inconvenience, highlighting the importance of considering patient comfort and quality of life in treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost analysis of leuprorelin acetate in Japanese pre-menopausal breast-cancer patients: comparison between 6-month and 3-month depot formulations. Goto, R., Uda, A., Hiroi, S., et al.[2018]

In a study of 457 breast cancer patients treated with a combination of neoadjuvant chemotherapy, hormonotherapy, and radiotherapy, 91% of patients in the first protocol and 94% in the second protocol experienced significant tumor regression, with 30% and 40% achieving complete clinical remission, respectively.

The treatment resulted in a high 5-year breast preservation rate of 94% and a local relapse rate of 15%, with disease-free and overall survival rates that are favorable compared to existing literature, indicating the effectiveness of this combined treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Primary chemotherapy in the treatment of breast cancer]. Auclerc, G., Borel, C., Khayat, D., et al.[2013]

The FACE trial is a large-scale study involving 4000 postmenopausal women with hormone receptor-positive, node-positive breast cancer, comparing the efficacy and safety of letrozole and anastrozole over a treatment period of up to 5 years.

The primary goal of the trial is to assess disease-free survival (DFS), while secondary objectives include evaluating overall survival (OS) and the time to distant metastases, which will provide comprehensive insights into the effectiveness of both treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The FACE trial: letrozole or anastrozole as initial adjuvant therapy? Jonat, W., Mundhenke, C.[2018]

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