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Trial Title:
Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT
NCT ID:
NCT05931302
Condition:
Lobular Breast Carcinoma
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Carcinoma, Lobular
FAPI-46
Conditions: Keywords:
68Ga-FAPI-46
18F-FDG PET
FAPα
staging
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
68Ga-FAPI-46 PET scan
Description:
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.
Arm group label:
68Ga-FAPI-46 PET scan + 18-FDG PET scan
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier Princesse Grace
Address:
City:
Monaco
Zip:
98000
Country:
Monaco
Status:
Recruiting
Contact:
Last name:
Florent Hugonnet, MD
Phone:
07 97 98 96 59
Phone ext:
+37
Email:
florent.hugonnet@chpg.mc
Start date:
November 16, 2023
Completion date:
April 2026
Lead sponsor:
Agency:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Agency class:
Other
Collaborator:
Agency:
Institut Curie
Agency class:
Other
Collaborator:
Agency:
Centre Antoine Lacassagne
Agency class:
Other
Source:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05931302
