Dotarem vs Gadobutrol Contrast for Breast MRI

Sponsor

University of Massachusetts, Worcester (Other)

Overall Status

Recruiting

CT.gov ID

NCT03730051

Collaborator

Guerbet (Industry)

258

Enrollment

Location

Arms

35.9

Anticipated Duration (Months)

7.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Diseases	Drug: Gadoterate meglumine Drug: Gadobutrol	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

258 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Gadoterate meglumine contrast 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 Participants randomized into this arm will receive gadoterate meglumine contrast for their scheduled breast MRI. Other Names: Dotarem
Experimental: Gadobutrol contrast 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 Participants randomized into this arm will receive gadobutrol contrast for their scheduled breast MRI. Other Names: Gadavist

Arm

Intervention/Treatment

Active Comparator: Gadoterate meglumine contrast

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

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

Other Names:

Dotarem

Experimental: Gadobutrol contrast

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

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

Other Names:

Gadavist

Outcome Measures

Primary Outcome Measures

Quality of breast MRI [6 months]
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 [12 months]
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 [12 months]
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 [12 months]
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 [12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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