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

Intermunicipal Hospital Center Toulon

Status

Active, not recruiting

Conditions

Lobular Breast Carcinoma

Treatments

Diagnostic Test: 68Ga-FAPI-46 PET scan

Study type

Interventional

Funder types

Other

Identifiers

NCT05931302

2023-CHITS-006

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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