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NCT05931302
Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT
Conditions: Lobular Breast Carcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Location: Centre Hospitalier Princesse Grace Monaco
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.
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
Source: ClinicalTrials.gov (NCT05931302). StuddyBuddy aggregates publicly available trial information.