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DETECTION RATE AND CLASSIFICATION OF BREAST LESIONS WITH DIGITAL MAMMOGRAPHY WITH CONTRAST MEDIUM (CEDM) ALONE AND IN COMBINATION WITH TOMOSYNTHESIS COMPARED TO MR IMAGING WITH GADOLINIUM IN DYNAMICS (DCE-MRI) - CEDM-MRI
EU CTIS ID: 2024-519017-62-00
What this study is testing
Evaluate, on a large case series, the detection rate and diagnostic accuracy, as well as the extent of breast pathology in terms of multifocality, multicentricity, and bilaterality, of CEDM alone and in combination with tomosynthesis, compared to MRI, considered both as CE-MRI and DCE-MRI.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age > 18 years
- Patients with suspected breast pathology or patients in pre-surgical staging for breast pathology already confirmed by conventional imaging (Ultrasound and/or traditional 2D Mammography) or by cytological/histopathological examination
- Full information about the study and signing of the informed consent to participate in the study
- Performance of exams at any time during the menstrual cycle
- Estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m², derived from serum creatinine measurement within two weeks prior to enrollment in the study
You likely can't join if
- Presence of pacemakers or other devices in the chest wall
- Allergies to iodinated contrast media and/or gadolinium
- Claustrophobia
- Acute renal failure of any severity due to hepatorenal syndrome and/or established in the preoperative period of liver transplantation
- Acute or chronic renal failure, moderate or severe (glomerular filtration rate <60 mL/min/1.73m²)
- Hypersensitivity to the active ingredient of the contrast medium or any of its excipients
See the full eligibility criteria
- Age > 18 years
- Patients with suspected breast pathology or patients in pre-surgical staging for breast pathology already confirmed by conventional imaging (Ultrasound and/or traditional 2D Mammography) or by cytological/histopathological examination
- Full information about the study and signing of the informed consent to participate in the study
- Performance of exams at any time during the menstrual cycle
- Estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m², derived from serum creatinine measurement within two weeks prior to enrollment in the study
- Presence of pacemakers or other devices in the chest wall
- Allergies to iodinated contrast media and/or gadolinium
- Claustrophobia
- Acute renal failure of any severity due to hepatorenal syndrome and/or established in the preoperative period of liver transplantation
- Acute or chronic renal failure, moderate or severe (glomerular filtration rate <60 mL/min/1.73m²)
- Hypersensitivity to the active ingredient of the contrast medium or any of its excipients
- Overt thyrotoxicosis
- Participation in a clinical trial where an investigational drug was administered within 30 days or 5 half-lives of the study drug
- Any clinical condition that, in the investigator's opinion, would render the patient unsuitable for the study
- Presence of breast implants
- Pregnancy or breastfeeding
- Inability to remain still during the examination
- Presence of severe heart disease and pulmonary hypertension
- Presence of acute brain disorders, history of epilepsy
- Presence of paraproteinemia (myelomatosis and Waldenström's macroglobulinemia)
- Presence of pheochromocytoma
- Presence of hyperthyroidism
- Inflammatory dermatological diseases (psoriasis, eczema, etc.)
- Presence of tattoos in the affected area
- Presence of nipple piercings that cannot be removed
- Internal/external devices that prevent proper patient positioning
- Metallic/electronic implants, metal fragments
- Specific breast morphology that hinders the examination (particularly overly large breasts)
- Allergies to metals
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.