[68Ga]Ga-FAPI-46: Participants receive the weakly radioactive drug \[68Ga\]Ga-FAPI-46 through their vein and lie in an imaging device (PET/MRI) for 30 minutes. After a break of 30 minutes, they will lie in the imaging device for another 15 minutes.
Study summary
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. The main question it aims to answer is:
How good can FAPI-PET/MRI diagnose hidden invasive breast cancer in DCIS?
Researchers will compare FAPI-PET/MRI results to tissue samples obtained from surgery treatment to see if the FAPI-PET/MRI images show invasive breast cancer certainly.
Participants will
* receive the radioactive drug and lie in an imaging device for 45 minutes including a break
* visit the clinic once again for a checkup and test
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion 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 the time period between signing of the informed consent form up to the final trial visit.
Exclusion Criteria:
* 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
Primary outcome measure(s)
Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI — Within one year after end of trial Sensitivity based on blinded readers' PET/MRI visual assessment: "Suspicious for occult carcinoma: Yes/No"
Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI — Within one year after end of trial Specificity based on blinded readers' PET/MRI visual assessment: "Suspicious for occult carcinoma: Yes/No"
Trial sites (2)
Facility
City
Region
Status
Department of Nuclear Medicine, University Hospital Essen
Essen
North Rhine-Westphalia
Not Yet Recruiting
Department of Nuclear Medicine, University Hospital Münster
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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