Dotarem vs Gadobutrol Contrast for Breast Cancer Imaging

Overseen by Nicholas Bloch, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Pregnancy, Breast cancer treatment, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

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.

How does the drug used in the Dotarem vs Gadobutrol Contrast for Breast Cancer Imaging trial differ from other drugs for breast cancer?

The Dotarem vs Gadobutrol trial focuses on comparing two contrast agents used in imaging for breast cancer, which is different from other treatments that typically involve drugs like tamoxifen or chemotherapy for directly treating the cancer. These contrast agents are used to enhance the quality of imaging scans, helping doctors better visualize the cancer, rather than treating the cancer itself. ^{1 2 3 4 5}

Research Team

Nicholas Bloch, MD

Principal Investigator

UMASS Medical School

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Dotarem (Contrast Agent)
• Gadobutrol (Contrast Agent)

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.

Participant Groups

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+

Dr. Eric W. Dickson

University of Massachusetts, Worcester

Chief Executive Officer since 2013

MD from UMass Chan Medical School, Master's in Health Care Management from Harvard University

Dr. Andy Karson

University of Massachusetts, Worcester

Chief Medical Officer

MD

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

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The management of locally advanced carcinoma of the breast by Nolvadex (tamoxifen): a pilot study. [2013]

2. England 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. [2018]

3. France pubmed.ncbi.nlm.nih.gov

[Primary chemotherapy in the treatment of breast cancer]. [2013]

4. Japan 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

The FACE trial: letrozole or anastrozole as initial adjuvant therapy? [2018]