Clinical trial · Interventional
FAP PET/CT for Staging Patients With Breast Cancer
[⁶⁸Ga]Ga-FAP-2286 PET/CT for Staging and Restaging Patients With Newly Diagnosed Primary Breast Cancer: a Phase II Study (FAPILOUS)
NCT07523607CI-TRIAL-00107959not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study aims to evaluate the clinical utility of \[68Ga\]Ga-FAP-2268 PET/CT for disease staging and assessment in patients with high-risk primary breast cancer. By targeting fibroblast activation protein (FAP), this novel imaging approach may offer improved tumor visualization compared to conventional imaging, which may help improve treatment planning.
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 |
|---|---|---|---|
| Breast Cancer Detection | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-FAP-2286 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-FAP-2286 PET/CT Imaging
- description
- Patients undergo intravenous administration (200 MBq) of 68Ga-FAP-2286 followed by PET/CT imaging for staging of high-risk primary breast cancer. A baseline scan is performed prior to initiation of therapy. Patients receiving neoadjuvant chemotherapy undergo an additional scan prior to surgery.
- interventionNames
- Drug: 68Ga-FAP-2286
Primary outcomes (2)
- measure
- Number of patients with nodal and distant metastases detected by [⁶⁸Ga]Ga-FAP-2286 PET/CT at baseline (pre-treatment staging)
- timeFrame
- Baseline (pre-treatment). Inclusion period 1 year.
- description
- Nodal and distant metastases will be identified on a per-patient and per-lesion basis using \[⁶⁸Ga\]Ga-FAP-2286 PET/CT in 65 patients undergoing baseline staging. PET/CT images will be read blinded. The reference standard is histopathology where available; if histopathology is not available, a composite of clinical and imaging follow-up will be used. Sensitivity and specificity with 95% confidence intervals will be calculated per patient and per lesion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male and females ≥ 18 years * Biopsy-verified newly diagnosed breast cancer * Can read and understand Danish * Capable of providing written and informed consent * Undergoing a routine \[¹⁸F\]FDG PET/CT scan as part of the clinical standard diagnostic workup Exclusion Criteria: * Pregnant or lactating women * Not able to participate in the conduct of the scan due to any reason ( e.g., claustrophobia or inability to lie still for entire imaging time) * Ongoing oncological treatment for another cancer * History of allergic reactions / hypersensitivity attributed to \[⁶⁸Ga\]Ga-FAP-2286.
References
Publications (0)
Data not yet available
No reference posted for this study.