NCT07071272 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
| NCT ID | NCT07071272 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliera Universitaria Integrata Verona |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 216 participants |
| Start Date | 2020-09-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 216 participants in total. It began in 2020-09-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. In patients undergoing neoadjuvant chemotherapy, which usually undergo MRI examination at the beginning, mid-cycle and at the end of chemotherapy treatment, a CEM will also be acquired same way at the beginning, mid-cycle and at the end of chemotherapy treatment. The study requires, for the execution of the contrast-enhanced mammography exam, the administration of an iodinated contrast medium that is completely analogous to that used in computed tomography.
Eligibility Criteria
Inclusion 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) Exclusion Criteria: * 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
Frequently Asked Questions
Who can join the NCT07071272 clinical trial?
This trial is open to female participants only, aged 30 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07071272 currently recruiting?
Yes, NCT07071272 is actively recruiting participants. Visit ClinicalTrials.gov or contact Azienda Ospedaliera Universitaria Integrata Verona to inquire about joining.
Where is the NCT07071272 trial being conducted?
This trial is being conducted at Verona, Italy.
Who is sponsoring the NCT07071272 clinical trial?
NCT07071272 is sponsored by Azienda Ospedaliera Universitaria Integrata Verona. The trial plans to enroll 216 participants.
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