Dotarem vs Gadobutrol Contrast for Breast MRI

Breast Diseases Clinical Trial

Official title:

Contrast Enhanced Breast MRI: Comparison of Two Macrocyclic Gadolinium-Based Contrast Agents: Gadoterate Meglumine (Dotarem) and Gadobutrol (Gadavist). A Prospective Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03730051
• Other study ID #: H00020209
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: March 1, 2026

Study information

• Verified date: April 2024
• Source: University of Massachusetts, Worcester
• Contact: Nicolas Bloch, MD
• Phone: 508-856-2144
• Email: b.nicolas.bloch[@]umassmemorial.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this randomized clinical trial, the investigators expect to demonstrate that the MRI contrast agent Dotarem is not less effective in contrast enhancement of breast lesions then Gadavist. Participants will be randomized to receive either Dotarem or Gadavist. In all cases, inclusion criteria will require patients having undergone or scheduled or most likely to be scheduled to undergo tissue sampling with histology results available. The patients will be prospectively and consecutively identified such that the majority of patients included will have been diagnosed with breast cancer, while including benign disease in the minority of patients in each arm. Following randomized enrollment, quantitative, semi-quantitative and qualitative image analysis will be performed to objectively assess for differences in image quality and diagnostic value.

Description:

A stratified randomization of participants based on the time of menstural cycle and breast density. Women will then receive their clinically indicated Breast MRI with contrast, using SOC procedures for weight-based dosage. After enrollment, MRI images and medical metadata will be abstracted using the hospital medical records in EPIC and PACS databases. Data to be collected from the medical record includes histology parameters: tumor, tumor type and size, grade, stage and personal data: MRN, accession number, date of birth, date of MRI, age, sex, race/ethnicity, family history. Images will be stripped of identifiers and then coded by a study ID using the third party SanteSoft Dicom Editor software. Medidata will also be coded and stored separately from a mastercode file linking the study ID with the following identifiable information: MRN, accession number, date of birth, and date of MRI. After a period of data collection, two radiologists blinded to the contrast agent will independently review the the MRIs. This qualitative review will consist of each exam being graded on a scale of 1-(Fail) to 5-(Excellent) contrast enhancement quality. Additionally, each blinded radiologist or designee will conduct the secondary quantitative measurements of the wash-in/wash-out contrast characteristics through use of computer aid design (CAD) in PACS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 258
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Females age 18 and older
• Scheduled to undergo a clinically indicated MRI of the breast with contrast.
• Have undergone, are scheduled to undergo, or are likely to be scheduled to undergo a breast tissue sampling exam with histology results available within 6 months of their MRI.

Exclusion Criteria:

• Pregnant
• Have already begun therapeutic treatment for breast cancer including surgery (lumpectomy or mastectomy), radiotherapy, or chemotherapy.
• Pre Menopause women outside of the 7-14 days from cycle

Related Conditions & MeSH terms

• Breast Diseases

Intervention

Drug:
• Gadoterate meglumine
Participants randomized into this arm will receive gadoterate meglumine contrast for their scheduled breast MRI.
• Gadobutrol
Participants randomized into this arm will receive gadobutrol contrast for their scheduled breast MRI.

Locations

Country	Name	City	State
United States	UMass Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Guerbet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of breast MRI	Each MRI exam will be graded by two radiologists blinded to the contrast agent using a scale of 1-(Fail- No enhancement or inadequate enhancement of the tumor) to 5-(Excellent- Strong and divisive contrast enhancement of entire tumor when compared to background. Clear and obvious tumor borders.) for the contrast enhancement quality.	6 months
Secondary	Wash-in/wash-out MRI contrast curve in breast tissues	The wash-in/wash-out MRI contrast curve will be assessed by software that analyzes the MRI images pixel by pixel for signal intensity changes over time on the breast MRI for each participant.	12 months
Secondary	Maximum relative enhancement (E(max) for contrast breast MRI	The maximum relative enhancement (E(max)) will be assessed by software that analyzes the MRI images pixel by pixel for signal intensity changes over time on the breast MRI for each participant.	12 months
Secondary	Time to peak enhancement (T(max)) for contrast breast MRI	The mean +/-sd of the time to peak enhancement (T(max)) will be assessed by software that analyzes the MRI images pixel by pixel for signal intensity changes over time on the breast MRI for each participant.	12 months
Secondary	Maximum enhancement slope for contrast breast MRI	The maximum enhancement slope will be assessed by software that analyzes the MRI images pixel by pixel for signal intensity changes over time on the breast MRI for each participant.	12 months