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Dotarem vs Gadobutrol Contrast for Breast MRI

Primary Purpose

Breast Diseases

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gadoterate meglumine
Gadobutrol
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Diseases focused on measuring Breast MRI, Mammography, Dotarem contrast, Gadobutrol contrast, wash-in/wash-out contrast curve, Contrast enhanced MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UMass Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Gadoterate meglumine contrast

Gadobutrol contrast

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
November 1, 2018
Last Updated
May 5, 2023
Sponsor
University of Massachusetts, Worcester
Collaborators
Guerbet
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1. Study Identification

Unique Protocol Identification Number
NCT03730051
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
Guerbet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Diseases
Keywords
Breast MRI, Mammography, Dotarem contrast, Gadobutrol contrast, wash-in/wash-out contrast curve, Contrast enhanced MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
258 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gadoterate meglumine contrast
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Gadobutrol contrast
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gadoterate meglumine
Other Intervention Name(s)
Dotarem
Intervention Description
Participants randomized into this arm will receive gadoterate meglumine contrast for their scheduled breast MRI.
Intervention Type
Drug
Intervention Name(s)
Gadobutrol
Other Intervention Name(s)
Gadavist
Intervention Description
Participants randomized into this arm will receive gadobutrol contrast for their scheduled breast MRI.
Primary Outcome Measure Information:
Title
Quality of breast MRI
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Wash-in/wash-out MRI contrast curve in breast tissues
Description
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.
Time Frame
12 months
Title
Maximum relative enhancement (E(max) for contrast breast MRI
Description
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.
Time Frame
12 months
Title
Time to peak enhancement (T(max)) for contrast breast MRI
Description
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.
Time Frame
12 months
Title
Maximum enhancement slope for contrast breast MRI
Description
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.
Time Frame
12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Bloch, MD
Phone
508-856-2144
Email
b.nicolas.bloch@umassmemorial.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Haskins
Phone
508-736-6251
Email
Sandra.Haskins@umassmed.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Bloch, MD
Organizational Affiliation
UMASS Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Bloch, MD
Phone
508-856-2144
Email
b.nicolas.bloch@umassmemorial.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Dotarem vs Gadobutrol Contrast for Breast MRI

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