Not Yet RecruitingNot Applicable

[68]GA-FAPI-46 PET/CT for the Diagnosis of Metastatic Lesions in Patients With Lobular Breast Cancer (ICL).

France45 participantsStarted 2026-03-30

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

FEMALE

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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.

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
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Questions for the trial coordinator

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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
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6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 6 weeks

Trial details

NCT IDNCT07313033

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-30

Contact for this trial

Nicolas Jacquet-Francillon

+33 4 72 35 69 99 nicolas.jacquet-francillon@chu-lyon.fr

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