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| Name | Class |
|---|---|
| Institut Curie | OTHER |
| Centre Antoine Lacassagne | OTHER |
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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.
Research hypothesis : Through better sensitivity (and specificity), 68Ga-FAPI-46-46 PET should provide a more accurate staging of lobular breast cancer than 18F-FDG PET. Participants with lobular breast carcinoma will then undergo 18F-FDG and 68Ga-FAPI-46 PET scan.
Primary objective of the study is to compare the sensitivity of 68Ga-FAPI-46 with the sensitivity of 18F-FDG in the detection of lobular breast carcinoma lesions, measured by positron emission tomography (PET). These results will be compared with the histological data collected before or during surgery (conventional histological data and immunohistochemical labeling of FAPĪ± on the sample obtained), clinical follow-up and any results of additional examinations carried out within the usual clinical follow-up of the patients.
Comparison of primary tumor and metastases uptake of 68Ga-FAPI-46 with the uptake of 18F-FDG, radiomic study of 68Ga-FAPI-46 PET and comparative radiomic study of 68Ga-FAPI-46 PET and 18F-FDG PET and comparison of the specificity of 68Ga-FAPI-46 with the specificity of 18F-FDG after a 12-month follow-up will also be performed as secondary objectives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-FAPI-46 PET scan + 18-FDG PET scan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-FAPI-46 PET scan | Diagnostic Test | 68Ga-FAPI-46 is a radiotracer for the detection of Fibroblast Activation Protein (FAP) in cancer patients. 68Ga-FAPI-46 will be administered intravenously at a dose of 2MBq/kg. Patients will be scanned 60 minutes after administration of 68Ga-FAPI-46. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of positive tumor lesions, i.e. confirmed by additional imaging, histopathology/biopsy or response to treatment (on imaging or clinical assessment) | Number of positive tumor lesions of 68Ga-FAPI-46 PET scan in comparison with 18F-FDG PET scan | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| SUVmaxFAPI and SUVmaxFDG for each target (Standardized Uptake Value) | Comparison of 68Ga-FAPI-46 and 18F-FDG Standardized Uptake Value in the primary tumor and possible metastases | Up to 21 days |
| SUVmaxFAPI/reference and SUVmaxFDG/reference activity ratios |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florent Hugonnet, MD | Centre Hospitalier Princesse Grace | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Princesse Grace | Monaco | 98000 | Monaco |
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| ID | Term |
|---|---|
| D018275 | Carcinoma, Lobular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Comparison of (SUVmaxFAPI/reference) and (SUVmaxFDG/reference) activity ratios. For the primary tumour, the reference activity will be measured in either the periphery of the lesion or on a homologous healthy tissue. For a vertebral metastasis, the reference activity will be measured in an adjacent healthy vertebra. |
| Up to 21 days |
| MTVFAPI and MTVFDG (Metabolic Tumor Volume) | Comparison of MTVFAPI and MTVFDG in the primary tumor and possible metastases | Up to 21 days |
| Number of discrepancies between FAPI and FDG PET scans | Discrepancies (discordant pairs) between 68Ga-FAPI-46 PET scan and 18F-FDG PET scan will be analyzed | Up to 21 days |
| Correlation between PET scan and FAPĪ± labeling | Correlation between PET scan results and measurement of the FAPĪ± labeling density on the biopsy | Up to 12 months |
| Correlation between PET scan and breast histology | Correlation between PET scans results and standard measurements in breast histology: OR (estrogen receptors), PR (progesterone receptors), HER2 (Human Epidermal Growth Factor Receptor-2), Ki-67 antigen, Ecadherin | Up to 12 months |
| Specificity comparison | Specificity of 68Ga-FAPI-46 PET scan will be compared to 18F-FDG PET scan specificity | 12 months |
| Correlation between tumor lesion radiomics and histological characteristics | 1st order characteristics reflecting the distribution of gray levels determined by radiomics study of 68Ga-FAPI PET scan and 18F-FDG PET scan | 12 months |
| Molecular biology analysis of tumor samples | Bioinformatics analysis of tumor sample celullar composition in terms of fibroblasts expressing FAP protein after total RNA extraction. | 12 months |
| D009369 | Neoplasms |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |