Dotarem vs Gadobutrol Contrast for Breast MRI

Phase

Condition

N/A

Treatment

Gadobutrol

Gadoterate meglumine

Clinical Study ID

NCT03730051

H00020209

Ages > 18
Female

Study 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.

Eligibility Criteria

Inclusion

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 abreast tissue sampling exam with histology results available within 6 months oftheir MRI.

Exclusion

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

Study Design

Gadobutrol

March 01, 2021

March 01, 2026

Study 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.

Connect with a study center

Boston Medical Center
Boston, Massachusetts 02118
United States
Site Not Available
UMass Medical School
Worcester, Massachusetts 01655
United States
Active - Recruiting

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