Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT
NCT ID: NCT05931302
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
40 participants
INTERVENTIONAL
2023-11-16
2026-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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68Ga-FAPI-46 PET scan + 18-FDG PET scan
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Institut Curie
OTHER
Centre Antoine Lacassagne
OTHER
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
OTHER
Responsible Party
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Principal Investigators
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Florent Hugonnet, MD
Role: STUDY_DIRECTOR
Centre Hospitalier Princesse Grace
Locations
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Centre Hospitalier Princesse Grace
Monaco, , Monaco
Countries
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Other Identifiers
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2023-CHITS-006
Identifier Type: -
Identifier Source: org_study_id
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