Clinical trial · Interventional
Multimodal Imaging With FAPI-PET/MRI in Breast Carcinoma-In-Situ for Detection of Occult Invasive Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Intraductal, Noninfiltrating | Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]Ga-FAPI-46 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- All participants receive the drug \[68Ga\]Ga-FAPI-46 and imaging
- interventionNames
- Drug: [68Ga]Ga-FAPI-46
Primary outcomes (2)
- measure
- Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI
- timeFrame
- Within one year after end of trial
- description
- Sensitivity based on blinded readers' PET/MRI visual assessment: "Suspicious for occult carcinoma: Yes/No"
- measure
- Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI
- timeFrame
- Within one year after end of trial
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available