Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT

Lobular Breast Carcinoma Clinical Trial

— GALILEE  

Official title:

Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05931302
• Other study ID #: 2023-CHITS-006
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2023
• Est. completion date: April 2026

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: Florent Hugonnet, MD
• Phone: 07 97 98 96 59
• Email: florent.hugonnet[@]chpg.mc
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 FAPα 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Carcinoma, Lobular
• Lobular Breast Carcinoma

Intervention

Diagnostic Test:
• 68Ga-FAPI-46 PET scan
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.

Locations

Country	Name	City	State
Monaco	Centre Hospitalier Princesse Grace	Monaco

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer	Centre Antoine Lacassagne, Institut Curie

Country where clinical trial is conducted

Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	SUVmaxFAPI/reference and SUVmaxFDG/reference activity ratios	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
Secondary	MTVFAPI and MTVFDG (Metabolic Tumor Volume)	Comparison of MTVFAPI and MTVFDG in the primary tumor and possible metastases	Up to 21 days
Secondary	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
Secondary	Correlation between PET scan and FAPa labeling	Correlation between PET scan results and measurement of the FAPa labeling density on the biopsy	Up to 12 months
Secondary	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
Secondary	Specificity comparison	Specificity of 68Ga-FAPI-46 PET scan will be compared to 18F-FDG PET scan specificity	12 months
Secondary	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