Clinical trial · Interventional
Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer
Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer. a Phase II Study to Evaluate the Comparison of 68Ga-FAPi-46 and 18F-FDG Uptake in Patients with Different Breast Cancer Subtypes
- 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 is a prospective, non-interventional, open-label study to evaluate the glucose metabolism and the expression of the imaging agent 68 Gallium-Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPi-46) with PET imaging, in woman affected by Breast Cancer (BC) and referred to diagnostic imaging work-up prior to primary therapy.
Conditions
Conditions (2)
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 Invasive | — | UNRESOLVED | — |
| Node Positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-FAPi-46 PET/CT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-FAPi-46 PET/CT
- description
- Study participants will undergo baseline assessments at enrollment with 68Ga-FAPi-46 PET/CT
- interventionNames
- Procedure: 68Ga-FAPi-46 PET/CT
Primary outcomes (1)
- measure
- Comparison of 68Ga-FAPi PET/CT and 18F-FDG PET/CT positivity rate
- timeFrame
- 3 months
- description
- Comparison of 68Ga-FAPi PET/CT and 18F-FDG PET/CT of positivity rate (percentage of detection of metastatic patients)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed, biopsy proven breast cancer; * Diagnosis of invasive breast cancer; * Tumor diameter more than 2 centimeters; * Radiological evidence of axillary nodes involvement; * 18F-FDG PET/CT performed as baseline diagnostic procedure, during routine diagnostic work-up; * 68Ga-FAPi-46 PET/CT performed within 4 weeks from 18F-FDG PET/CT; * Patients suitable to primary treatment (surgery or neo-adjuvant therapy); * 68Ga-FAPi-46 PET/CT performed within 8 weeks from primary treatment; * Female patients; * Age ≥18; * Willing to sign informed consent form. Exclusion Criteria: * Pregnant or nursing patients; * Unable to stay flat and cannot tolerate PET scan; * Sample tissue from biopsy unavailable for assessing Fibroblast Activation Protein (FAP) expression; * Eastern Cooperative Oncology Group (ECOG) performance status ≥2.
References
Publications (0)
Data not yet available