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Multimodal Imaging with FAPI-PET/MRI in Breast Carcinoma-In-Situ for Detection of occult Invasive cancer (MI-CISDIR)
EU CTIS ID: 2023-509860-47-00
What this study is testing
Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/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
- Newly diagnosed DCIS with extent in mammography, MRI or ultrasound suspected to range > 4 cm
- Planned DCIS resection (breast conserving or mastectomy) as per guideline recommendation
- Age ≥ 18 years
- Written informed consent
- For women of childbearing potential: confirmed menstrual period (if applicable) and a negative highly sensitive urine or serum pregnancy test
- Women of childbearing potential (WOCBP) and fertile male patients with partners of childbearing/reproductive potential must agree to use highly effective contraception (Pearl index < 1) when sexually active. This applies for the time period between signing of the informed consent form up to the final trial visit.
You likely can't join if
- Contraindications for MRI (specific metallic implants, severe claustrophobia, history of anaphylaxis following MRI contrast agent application)
- GFR < 30 mL/(min∙1.73 m^2)
- Current pregnancy or pregnancy within 8 weeks before begin of study participation
- Current nursing or nursing within 8 weeks before begin of study participation
- Inability to understand the nature, risks, and benefits of the study
- History of diagnosis of ipsilateral invasive breast cancer
See the full eligibility criteria
- Newly diagnosed DCIS with extent in mammography, MRI or ultrasound suspected to range > 4 cm
- Planned DCIS resection (breast conserving or mastectomy) as per guideline recommendation
- Age ≥ 18 years
- Written informed consent
- For women of childbearing potential: confirmed menstrual period (if applicable) and a negative highly sensitive urine or serum pregnancy test
- Women of childbearing potential (WOCBP) and fertile male patients with partners of childbearing/reproductive potential must agree to use highly effective contraception (Pearl index < 1) when sexually active. This applies for the time period between signing of the informed consent form up to the final trial visit.
- Contraindications for MRI (specific metallic implants, severe claustrophobia, history of anaphylaxis following MRI contrast agent application)
- GFR < 30 mL/(min∙1.73 m^2)
- Current pregnancy or pregnancy within 8 weeks before begin of study participation
- Current nursing or nursing within 8 weeks before begin of study participation
- Inability to understand the nature, risks, and benefits of the study
- History of diagnosis of ipsilateral invasive breast cancer
- Concurrent diagnosis of contralateral invasive cancer, if not curatively treated by surgery > 1 year ago
- Known hypersensitivity to the active substance or to any of the excipients of the IMP
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 all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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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.