NCT03730051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2018

Completed
2.3 years until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2025

Enrollment Period

4.8 years

First QC Date

November 1, 2018

Last Update Submit

March 13, 2026

Conditions

Breast Diseases

Keywords

Breast MRIMammographyDotarem contrastGadobutrol contrastwash-in/wash-out contrast curveContrast enhanced MRI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Wash-in/wash-out MRI contrast curve in breast tissues

    12 months

  • Maximum relative enhancement (E(max) for contrast breast MRI

    12 months

  • Time to peak enhancement (T(max)) for contrast breast MRI

    12 months

  • Maximum enhancement slope for contrast breast MRI

    12 months

Study Arms (2)

Gadoterate meglumine contrast

ACTIVE COMPARATOR

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.

Drug: Gadoterate meglumine

Gadobutrol contrast

EXPERIMENTAL

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.

Drug: Gadobutrol

Interventions

Gadoterate meglumineDRUG

Participants randomized into this arm will receive gadoterate meglumine contrast for their scheduled breast MRI.

Also known as: Dotarem
Gadoterate meglumine contrast
GadobutrolDRUG

Participants randomized into this arm will receive gadobutrol contrast for their scheduled breast MRI.

Also known as: Gadavist
Gadobutrol contrast

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMass Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Breast Diseases

Interventions

gadoterate megluminegadobutrol

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nicholas Bloch, MD

    UMASS Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 1, 2018

First Posted

November 5, 2018

Study Start

March 1, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 17, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)