Clinical trial · Interventional
Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT
NCT05931302CI-TRIAL-00117086GALILEEactive not recruitingN/AClinicalTrials.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)
Lobular Breast cancer staging with 18F-fluorodeoxyglucose positron emission tomography (18F-FDG PET) is not optimal due to the poor accumulation of 18F-FDG in the tumour. Through better sensitivity (and specificity), 68Ga-FAPI-46-46 PET should provide a more accurate staging of lobular breast cancer than 18F-FDG PET.
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 |
|---|---|---|---|
| Lobular Breast Carcinoma | Breast Lobular Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-FAPI-46 PET scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-FAPI-46 PET scan + 18-FDG PET scan
- interventionNames
- Diagnostic Test: 68Ga-FAPI-46 PET scan
Primary outcomes (1)
- measure
- Number of positive tumor lesions, i.e. confirmed by additional imaging, histopathology/biopsy or response to treatment (on imaging or clinical assessment)
- timeFrame
- Up to 12 months
- description
- Number of positive tumor lesions of 68Ga-FAPI-46 PET scan in comparison with 18F-FDG PET scan
Secondary outcomes (9)
- measure
- SUVmaxFAPI and SUVmaxFDG for each target (Standardized Uptake Value)
- timeFrame
- Up to 21 days
- description
- Comparison of 68Ga-FAPI-46 and 18F-FDG Standardized Uptake Value in the primary tumor and possible metastases
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age greater than or equal to 18 years * ECOG from 0 to 2 * Histological diagnosis of Lobular Carcinoma of the breast based on a breast biopsy * Patient naïve to any treatment for lobular breast carcinoma * Women of childbearing age should have an adequate method of contraception * Patient having voluntarily accepted to participate in the study and signed the informed consent * Minimum tumor stage IIA * Sufficient histological material in the biopsy or the surgical specimen, if the biopsy is insufficient Exclusion Criteria: * PET scan contraindications: severe claustrophobia, unbalanced diabetes during 18F-FDG PET scans (fasting capillary blood sugar ≥ 11 mmol) * Hormone therapy started * 18F-FDG PET scan \> 21 days * Pregnant women, parturients and nursing mothers * Persons deprived of liberty by a judicial or administrative decision * Persons admitted to a health or social establishment for purposes other than research * Adults who are the subject of a legal protection measure or who are unable to express their consent
References
Publications (0)
Data not yet available
No reference posted for this study.