Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:20 AM
Study NCT ID:
NCT07313033
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-16
First Post:
2025-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
[68]GA-FAPI-46 PET/CT for the Diagnosis of Metastatic Lesions in Patients With Lobular Breast Cancer (ICL).
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
[68]GA-FAPI-46 PET/CT for the Diagnosis of Metastatic Lesions in Patients With Lobular Breast Cancer (ICL)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAPI-CL
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2025-524897-40-00 | CTIS | None | View |