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Evaluation of the use of contrast agent in mammography to improve the specificity of breast cancer diagnosis
EU CTIS ID: 2024-517486-16-00
What this study is testing
To evaluate the role of Contrast-Enhanced Spectral Mammography in the diagnostic workup of breast cancer
- 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
- Woman with suspicious breast lesions from FFDM, US and/or MR imaging and for whom a presurgical evaluation is recommended. Only women in the BI-RADS 4 radiological category risk will be included in the study.
- The subject must be in sufficient good health to be able to undergo standard of care and CESM examinations. Only patients with ECOG scale 0 or 1 performance status will be included in the study.
- Only patients with an age > or = to 18 can be included in the study.
You likely can't join if
- The subject is known to have risks of adverse effects with iodine contrast agents.
- Patients with a clinical examination positive for regional lymph nodes or suspected for distant metastases (bones, brain, liver and lungs).
- The subject is asymptomatic and without suspicious findings from routine imaging.
- The subject is participating or has participated (within the prior 30 days) in another clinical trial.
- Proved or supposed pregnancy. For all women of child bearing potential a pregnancy test will be performed before undergoing CESM.
- Patients with impairment of renal function (GFR < 30 ml/min).
See the full eligibility criteria
- Woman with suspicious breast lesions from FFDM, US and/or MR imaging and for whom a presurgical evaluation is recommended. Only women in the BI-RADS 4 radiological category risk will be included in the study.
- The subject must be in sufficient good health to be able to undergo standard of care and CESM examinations. Only patients with ECOG scale 0 or 1 performance status will be included in the study.
- Only patients with an age > or = to 18 can be included in the study.
- The subject is known to have risks of adverse effects with iodine contrast agents.
- Patients with a clinical examination positive for regional lymph nodes or suspected for distant metastases (bones, brain, liver and lungs).
- The subject is asymptomatic and without suspicious findings from routine imaging.
- The subject is participating or has participated (within the prior 30 days) in another clinical trial.
- Proved or supposed pregnancy. For all women of child bearing potential a pregnancy test will be performed before undergoing CESM.
- Patients with impairment of renal function (GFR < 30 ml/min).
- History of bronchial asthma or other allergic disorders.
- Manifest hyperthyroidism. Testing of thyroid function prior to Ultravist® administration will be performed in patients with suspected hyperthyroidism.
- Patients with risk of serious adverse reactions such as cardiac disease, heart failure, uncontrolled arterial hypertension.
- Patients in therapy with biguanide such as metformin, interleukine 2 and radioactive iodine.
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.