BridgeMD
New treatment option for Carcinoma, Intraductal, Noninfiltrating
Official title Multimodal Imaging With FAPI-PET/MRI in Breast Carcinoma-In-Situ for Detection of Occult Invasive Cancer
ClinicalTrials.gov ID: NCT06540872
What this study is testing
What is [68Ga]Ga-FAPI-46?
[68Ga]Ga-FAPI-46 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for carcinoma, intraductal, noninfiltrating.
Also referred to as [68Ga]FAPI-46.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- DCIS (ductal carcinoma in situ) is a common pre-stage for breast cancer. The goal of this clinical trial is to learn if FAPI-PET/MRI (an imaging technique with a weakly radioactive drug) helps to diagnose hidden invasive breast cancer in participants with DCIS.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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
- Written informed consent
- For women of child bearing potential: confirmed menstrual period (if applicable) and a negative highly sensitive urine or serum pregnancy test
- Women of childbearing potential (WOCBP) and male patients with partners of childbearing/reproductive potential must agree to use highly effective...
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 m²)
- Current pregnancy or within last 8 weeks before begin of study participation
- Current nursing or within last 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
- Written informed consent
- For women of child bearing potential: confirmed menstrual period (if applicable) and a negative highly sensitive urine or serum pregnancy test
- Women of childbearing potential (WOCBP) and male patients with partners of childbearing/reproductive potential must agree to use highly effective contraception (Pearl index \< 1) when sexually active. This applies for...
- Contraindications for MRI (specific metallic implants, severe claustrophobia, history of anaphylaxis following MRI contrast agent application)
- GFR \< 30 mL/(min∙1.73 m²)
- Current pregnancy or within last 8 weeks before begin of study participation
- Current nursing or within last 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 Investigational Medicinal Product
The study team makes the final eligibility decision.
Where it's taking place
- Essen, North Rhine-Westphalia, Germany
- Münster, North Rhine-Westphalia, Germany
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Essen, North Rhine-Westphalia, Germany; Münster, North Rhine-Westphalia, Germany. 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.