Clinical trial NCT03730051: Dotarem vs Gadobutrol Contrast for Breast MRI
Official title: Contrast Enhanced Breast MRI: Comparison of Two Macrocyclic Gadolinium-Based Contrast Agents: Gadoterate Meglumine (Dotarem) and Gadobutrol (Gadavist). A Prospective Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Breast Diseases
Keywords: Breast MRI
Mammography
Dotarem contrast
Gadobutrol contrast
wash-in/wash-out contrast curve
Contrast enhanced MRI
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Guerbet
First posted: 2018-11-05
Enrollment: 258
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of breast MRI
timeFrame: 6 months
Secondary outcomes:
measure: Wash-in/wash-out MRI contrast curve in breast tissues
timeFrame: 12 months
measure: Maximum relative enhancement (E(max) for contrast breast MRI
timeFrame: 12 months
measure: Time to peak enhancement (T(max)) for contrast breast MRI
timeFrame: 12 months
measure: Maximum enhancement slope for contrast breast MRI
timeFrame: 12 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Medical School
state: Massachusetts
Study officials:
affiliation: UMASS Medical School
name: Nicholas Bloch, MD
role: PRINCIPAL_INVESTIGATOR
References: