[68]GA-FAPI-46 PET/CT for the Diagnosis of Metastatic Lesions in Patients With Lobular Breast Cancer (ICL).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [68]GA-FAPI-46 PET scan.
- Who it may be relevant to
- Registry conditions: Lobular Carcinoma, Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
[68]GA-FAPI-46 PET/CT for the Diagnosis of Metastatic Lesions in Patients With Lobular Breast Cancer (ICL)
Overview
Invasive squamous cell carcinoma (ISCC) represents 5 to 15% of breast cancers. Despite the rarity of this pathology, the number of patients with Invasive squamous cell carcinoma treated at HCL is significant. 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. The investigators 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 . The investigators would like to compare the \[18\]F-FDG PET/CT technique currently used to this new emerging modality. The investigators 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. The investigators 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. The investigators 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.
Interventions
- Other [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)
Primary outcome measures
- Percentage of patients for whom at least one secondary lesion is demonstrated in [68]Ga-FAPI and confirmed by histology, when [18]F-FDG PET/CT is negative [Time frame: 6 weeks]
Secondary outcome measures (4)
- Average number per patient of lesions demonstrated in [68]Ga-FAPI, not seen in [18F]-FDG [Time frame: 6 weeks]
- Number of lesions positive on histology, among the lesions visualized on PET/CT with [68]Ga-FAPI (and in the case of negative histology, identify the differential diagnoses) [Time frame: 6 weeks]
- Evaluate the Positive Predictive Value of [68]Ga-FAPI PET/CT at the patient level, in patients negative on [18]F-FDG PET/CT [Time frame: 6 weeks]
- Analyze the semi-quantitative values of the PET signal by describing the [68Ga]-FAPI lesional SUVs, compared to the vascular and hepatic background [Time frame: 6 weeks]
Eligibility criteria
Inclusion criteria
- Adult patient (≥18 years old),
- 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
- Pregnant, parturient or breastfeeding women. A pregnancy test before inclusion will be carried out for women of childbearing age.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Lyon sud Hospital center - Hospices Civils de Lyon — Lyon
Identifiers
NCT: NCT07313033 · 69HCL23_1133 · 2025-524897-40-00