[68]GA-FAPI-46 PET/CT for the Diagnosis of Metastatic Lesions in Patients With Lobular Breast Cancer (ICL).
NCT ID: NCT07313033
Last Updated: 2025-12-31
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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NOT_YET_RECRUITING
NA
45 participants
INTERVENTIONAL
2026-03-30
2027-08-30
Brief Summary
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Patients at risk of metastasis are usually referred to the HCL Nuclear Medicine departments to perform positron emission tomography - computed tomography (PET/CT) with \[18\]F-FDG as an extension assessment. We know that \[18\]F-FDG PET/CT has limited diagnostic performance for assessing the extent of breast cancer with a sensitivity of 66-96% for all histologies combined. For the ISCC, these performances are even lower with average Standard Uptake Value (SUV) values of 3.4 \[2.8-3.9\] versus 6.6 \[4.8-9.7\] for the others histological types of breast cancer. False negatives in \[18\]F-FDG PET/CT are due to an insufficient osteoblastic and immune response in the tumor stroma. Avril \& al. showed 65.2% false negatives with \[18\]F-FDG PET/CT for ISCC. This is why the search for new imaging techniques in this indication is particularly relevant.
Targeting fibroblast activation protein (FAP), a type II membrane glycoprotein belonging to the dipeptidyl peptidase-4 family, is a promising strategy for imaging tumor stroma, particularly in epithelial carcinomas .
We would like to compare the \[18\]F-FDG PET/CT technique currently used to this new emerging modality.
We hypothesize superior diagnostic performance of \[68\]Ga-FAPI PET/CT compared to \[18\]F-FDG PET/CT for the assessment of ISCC extension, with a gold standard histological.
We translate this into the hypothesis of finding 30% of positive FAPI PET when the \[18F\]FDG PET/CT is negative or doubtful.
The advantage of this project and this new imaging modality is to not undertreat patients wrongly classified as non-metastatic. We therefore wish to offer \[68\]Ga-FAPI PET/CT to patients with negative \[18\]F-FDG PET/CT.
The FAPICL project constitutes a seed project before a larger structuring study.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Control
Adult patients with infiltrating lobular carcinomas. Patients must have had a negative or doubtful 18F-FDG PET/CT scan as part of their routine care pathway
[68]GA-FAPI-46 PET scan
Realization of a \[68\]GA-FAPI-46 PET scan to detect at least one \[68\]GA-FAPI positive lesion (confirmed by histology)
Interventions
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[68]GA-FAPI-46 PET scan
Realization of a \[68\]GA-FAPI-46 PET scan to detect at least one \[68\]GA-FAPI positive lesion (confirmed by histology)
Eligibility Criteria
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Inclusion Criteria
* Beneficiary or entitled to a social security system;
* Patient having agreed to participate in the study and signed written informed consent;
* 18F-FDG PET/CT performed as part of the assessment of extension of an infiltrating lobular carcinoma, the result of which is negative or doubtful on at least one lesion.
Exclusion Criteria
* Persons deprived of liberty by a judicial or administrative decision
* People receiving psychiatric care
* People admitted to a health or social establishment for purposes other than research
* Adults subject to a legal protection measure (guardianship, curatorship)
* Subjects participating in another interventional research including an exclusion period still ongoing at inclusion.
18 Years
FEMALE
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Lyon sud Hospital center - Hospices Civils de Lyon
Lyon, , France
Countries
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Central Contacts
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Facility Contacts
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Nicolas Jacquet-Francillon
Role: primary
Other Identifiers
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2025-524897-40-00
Identifier Type: CTIS
Identifier Source: secondary_id
69HCL23_1133
Identifier Type: -
Identifier Source: org_study_id