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

NCT07313033 | Not Yet Recruiting

• 2 other identifiers: 69HCL23_11332025-524897-40-00
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Lobular Carcinoma; Breast Cancer

Keywords

lobular carcinoma; medical imaging at [68]GA-FAPI-46 PET scan; oncology; gynecology

Outcome Measures

Primary Outcomes (1)

• 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

  6 weeks

Secondary Outcomes (4)

• Average number per patient of lesions demonstrated in [68]Ga-FAPI, not seen in [18F]-FDG

  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)

  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

  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

  6 weeks

Study Arms (1)

Control

EXPERIMENTAL

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

Other: [68]GA-FAPI-46 PET scan

Interventions

[68]GA-FAPI-46 PET scan OTHER

Realization of a \[68\]GA-FAPI-46 PET scan to detect at least one \[68\]GA-FAPI positive lesion (confirmed by histology)

Control

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• F-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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Lyon sud Hospital center - Hospices Civils de Lyon

Lyon, France

Location

MeSH Terms

Conditions

Carcinoma, Lobular; Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Nicolas Jacquet-Francillon

CONTACT

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

Adeline Mansuy

CONTACT

+33 4 72 11 51 70; Adeline.mansuy@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will carry out 2 examinations \[18F\]-FDG and \[68\]GA-FAPI-46 PET scan and the gold standard will be histology

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 31, 2025
• Study Start: March 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: January 16, 2026

Record last verified: 2025-12

Locations

FR (1)