Clinical trial NCT05931302: Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT
Official title: Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lobular Breast Carcinoma
Keywords: 68Ga-FAPI-46
18F-FDG PET
FAPα
staging
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
Collaborators: name: Institut Curie
name: Centre Antoine Lacassagne
First posted: 2023-07-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
measure: SUVmaxFAPI and SUVmaxFDG for each target (Standardized Uptake Value)
timeFrame: Up to 21 days
measure: SUVmaxFAPI/reference and SUVmaxFDG/reference activity ratios
timeFrame: Up to 21 days
measure: MTVFAPI and MTVFDG (Metabolic Tumor Volume)
timeFrame: Up to 21 days
measure: Number of discrepancies between FAPI and FDG PET scans
timeFrame: Up to 21 days
measure: Correlation between PET scan and FAPα labeling
timeFrame: Up to 12 months
measure: Correlation between PET scan and breast histology
timeFrame: Up to 12 months
measure: Specificity comparison
timeFrame: 12 months
measure: Correlation between tumor lesion radiomics and histological characteristics
timeFrame: 12 months
Other outcomes:
Locations:
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
affiliation: Centre Hospitalier Princesse Grace
name: Florent Hugonnet, MD
role: STUDY_DIRECTOR
References: