NCT07313033: FAPI-CL

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

Not yet recruiting NA Last updated 16 January 2026

What this trial tests

NA trial testing [68]GA-FAPI-46 PET scan in Lobular Carcinoma in 45 participants. Not yet recruiting.

Timeline

30 March 2026

Primary endpoint
30 May 2027

30 August 2027

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	45
Start date	30 March 2026
Primary completion	30 May 2027
Estimated completion	30 August 2027
Sites	1 location across France

Drugs / interventions tested

• [68]GA-FAPI-46 PET scan

Conditions studied

• Lobular Carcinoma — all drugs for Lobular Carcinoma →
• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, female only, with Lobular Carcinoma or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.