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Compares treatment options for Breast Cancer
Official title Non-inferiority Study of Contrast-enhanced Digital Mammography (CEDM) vs Magnetic Resonance Imaging (MRI) in Terms of Diagnostic Accuracy in Patients Undergoing Preoperative Staging of Established Invasive Breast Cancer
ClinicalTrials.gov ID: NCT07071272
What this study is testing
- What it's testing
- The general objective of the study is to verify the diagnostic accuracy of contrast-enhanced mammography (CEM) compared to breast magnetic resonance imaging in patients undergoing preoperative staging for breast neoformations that have already been diagnosed and in patients undergoing neoadjuvant chemotherapy. In addition to performing a preoperative breast resonance imaging, which is always performed in these patients, one contrast-enhanced mammography per patient is planned.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 and older, women only
You may be able to join if
- women in pre-hospitalization with already established invasive breast cancer (T1-2)
- over the age of 30
- with BI-RADS mammography pattern\> 1
- Written and signed informed consent for research
- Negative history of adverse events to the use of iodinated and chelated contrast media of gadolinium
You likely can't join if
- women with breast implants
- women under the age of 30
- Any contraindication to performing the MRI exam
- Women with known BRCA 1 and BRCA 2 mutation
See the full eligibility criteria
- women in pre-hospitalization with already established invasive breast cancer (T1-2)
- over the age of 30
- with BI-RADS mammography pattern\> 1
- Written and signed informed consent for research
- Negative history of adverse events to the use of iodinated and chelated contrast media of gadolinium
- No significant renal impairment (EGFR\> 30 mL / min within three months before administration of the iodinated contrast medium)
- women with breast implants
- women under the age of 30
- Any contraindication to performing the MRI exam
- Women with known BRCA 1 and BRCA 2 mutation
The study team makes the final eligibility decision.
Where it's taking place
- Verona, Italy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 30 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Verona, Italy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.