Clinical trial · Interventional
Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET
Improving Detection and Outcomes in Patients With Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAPI PET Imaging
NCT07285993CI-TRIAL-00110064not 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 is a pilot clinical imaging trial of a prospective, head-to-head comparison of 18F-Fibroblast Activation Protein Inhibitor (FAPI)-74 PET/CT versus standard-of-care 18F-Fluorodeoxyglucose (FDG) PET/CT in 15 patients with metastatic invasive lobular breast cancer (ILC). Patients will undergo both 18F-FDG PET/CT and 18F-FAPI-74 PET/CT within a 2-week period (14 days + 7 days) to compare lesions, tumor detection rates, and PET lesion intensity, as well as to assess the clinical value of the PET scans from the treating physician's and the patient's perspective.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Invasive Lobular Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FAPI-74 | Drug | — | UNRESOLVED |
| 18F-FDG | Drug | — | UNRESOLVED |
| PET/CT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-FAPI-74 PET/CT and 18F-FDG PET/CT
- description
- Study participants will undergo both standard-of-care whole body 18F-FDG PET/CT scan and investigational whole-body scan 18F-FAPI-74 PET/CT.
- interventionNames
- Drug: 18F-FAPI-74
- Drug: 18F-FDG
- Procedure: PET/CT
Primary outcomes (1)
- measure
- Proportion of lesions detected by 18F-FAPI-74 PET/CT
- timeFrame
- End of study, at 1 month
- description
- Proportion of lesions detected by 18F-FAPI-74 PET/CT but not by 18F-FDG PET/CT. All lesions will be mapped across both imaging modalities to determine whether they were detected by FAPI PET/CT but not by FDG PET/CT.
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study * Females; Age \> 18 years of age * Diagnosis of invasive lobular breast cancer, with pathologically confirmed metastatic disease. * ECOG performance status 0-2 * No planned change in anticancer therapy between FDG and FAPI PET scans Exclusion Criteria: * Patients who are pregnant or lactating * Patients who cannot undergo PET/CT scanning * Patients with total serum bilirubin or serum creatinine \> 1.5 times the upper limit of normal
References
Publications (25)
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- BACKGROUNDDavis AA, Gerratana L, Clifton K, Medford AJ, Velimirovic M, Hensing WL, Bucheit L, Shah AN, D'Amico P, Reduzzi C, Zhang Q, Dai CS, Denault EN, Bagegni NA, Opyrchal M, Ademuyiwa FO, Bose R, Gradishar WJ, Behdad A, Ma CX, Bardia A, Cristofanilli M. Circulating tumour DNA characterisation of invasive lobular carcinoma in patients with metastatic breast cancer. EBioMedicine. 2022 Dec;86:104316. doi: 10.1016/j.ebiom.2022.104316. Epub 2022 Nov 1. PMID 36332363
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