Dotarem vs Gadobutrol Contrast for Breast Cancer Imaging
Recruiting in Palo Alto (17 mi)
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.
12345Eligibility 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
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UMass Medical SchoolWorcester, MA
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Who Is Running the Clinical Trial?
University of Massachusetts, WorcesterLead Sponsor
GuerbetIndustry Sponsor
References
The management of locally advanced carcinoma of the breast by Nolvadex (tamoxifen): a pilot study. [2013]Fifty-one postmenopausal women with locally advanced breast cancer were treated initially by Nolvadex (Tamoxifen, ICI) alone and followed prospectively between 1974 and 1982. Twenty-three patients (40%) showed an objective response to therapy of whom 17 (75%) remain in remission at median follow-up of 36 months. Patients who failed to respond to Nolvadex therapy were treated by radiotherapy which achieved local control in 64%, with 10 months median duration. Nolvadex therapy conveys a good quality lengthy remission to a sizeable minority of patients. The majority of those who fail to respond are satisfactorily managed by radiotherapy.
Cost analysis of leuprorelin acetate in Japanese pre-menopausal breast-cancer patients: comparison between 6-month and 3-month depot formulations. [2018]The aim in this study is to evaluate economic value for leuprorelin acetate 6-month depot compared with leuprorelin acetate 3-month depot in Japanese pre-menopausal breast cancer patients from a societal perspective.
[Primary chemotherapy in the treatment of breast cancer]. [2013]Between 1980 and 1992, 457 consecutive patients with initial breast cancer entered two successive protocols combining neoadjuvant chemotherapy, hormonotherapy (tamoxifen) and locoregional radiotherapy (teleradiotherapy and boost by iridium) as exclusive locoregional treatment. Cytological diagnosis, hormone receptors, cytological grading were provided by fine needle aspiration. Both protocols included velbe, thiotepa, methotrexate, 5FU and adriamycin with some minor differences regarding the schedule of doses and their number during induction and during the consolidation phase. In both studies, over 50% patients had locally advanced breast cancer (IIb, IIIa or IIIb). Chemotherapy induced tumor regression over 50% in 91% patients of the first protocol (30% complete clinical remission CR) and in 94% patients of the 2nd protocol (40% CR): in this protocol 20 poor responders were given a rescue protocol (2 CR; 9 partial remissions). The 5 year actuarial rate of breast preservation is 94% and the 5 year actuarial rate of local relapses is 15%. The cosmetic results according to Danoff are excellent 20%, good 55%, mean 35%. Disease free survival and overall survival compare favorably to published data: they depend on TNM stages, tumor differentiation and chemotherapy induced early tumor regression.
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]Previously, we conducted the 5-year open-label, randomized controlled trial (RCT) of leuprorelin adjuvant therapy in post-operative premenopausal patients with endocrine-responsive breast cancer, which was a pilot study to investigate the optimal duration of leuprorelin treatment. Since, however, long-term outcomes became required for the adjuvant endocrine therapy, we performed this follow-up observation study.
The FACE trial: letrozole or anastrozole as initial adjuvant therapy? [2018]The adjuvant Femara versus Anastrozole Clinical Evaluation (FACE) trial compares upfront therapy letrozole 2.5 mg with anastrozole 1 mg daily for up to 5 years in postmenopausal, hormone receptor-positive, node-positive breast cancer patients. This phase III b open label, randomized, multicenter study will include 4000. patients from up to 250 international sites. Patients will be stratified by degree of lymph node involvement and HER-2 status. Any efficacy and safety difference of the two drugs will be reported. Primary objective is DFS, secondary objectives are safety, OS, time to distant metastases, time to contralateral breast cancer and breast cancer specific survival.