Dotarem vs Gadobutrol Contrast for Breast MRI
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/28/2019 |
| Start Date: | April 2019 |
| End Date: | January 2021 |
| Contact: | Nicolas Bloch, MD |
| Email: | nicolas.bloch@bmc.org |
| Phone: | 617-638-7294 |
Contrast Enhanced Breast MRI: Comparison of Two Macrocyclic Gadolinium-Based Contrast Agents: Gadoterate Meglumine (Dotarem) and Gadobutrol (Gadavist). A Prospective Study.
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.
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.
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.
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.
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
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