NCT04320030

[18F]-DPA-714 PET/CT (Positron Emission Tomography/Computerized Tomography) in Triple Negative Breast Cancers

Pilot Feasibility Study: Inflammation and Presence of M2 Macrophages Explorations With[18F]-DPA-714 PET/CT in Triple Negative Breast Cancers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Institut Cancerologie de l'Ouest · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II study is assessing the correlation between M1/M2 macrophage polarization determined by tumor immunohistochemistry analysis and \[18F\]DPA-714 PET/CT binding (qualitative and texture analysis) in patients with operable triple negative breast cancer.

Detailed description

The purpose of this study is to evaluate the correlation of inflammation assessed by M1/M2 macrophage polarization determined by tumor immunohistochemistry analysis and \[18F\] DPA-714 PET imaging by using qualitative and image texture analysis in patients with triple negative breast cancer. Patients receive pre-therapeutic diffusion-weighted breast MRI (Magnetic resonance imaging) and 18FDG (fluorodeoxyglucose) PET/CT (Positron Emission Tomography/Computerized Tomography) scan within 30 days before enrollment. \[18F\] DPA-714 PET/CT scan is performed before surgery. About 3 MBq/Kg of \[18F\] DPA-714 are injected intravenously, two acquisition sequences are performed following injection and 60 minutes after injection in order to evaluate early and late tumor uptake of \[18F\] DPA-714. Surgery is scheduled after \[18F\] DPA-714 PET/CT scan. Tissue samples from breast surgery are used to assess M1 and M2 macrophages expression and to perform tumor molecular subtyping by Immunohistochemical analysis. Tumor Autoradiography with the TSPO (18 kDa Translocator Protein) ligand \[18F\]DPA-714 will be also assessed on tumor tissue. A blood sample is performed before \[18F\] DPA-714 PET/CT scan in order to assess the genotyping of TSPO (18 kDa Translocator Protein) gene.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	[18F]-DPA-714 PET/CT scan	Pretherapeutic \[18F\]-DPA-714 PET/CT scan

Timeline

• Start date: 2020-06-11
• Primary completion: 2021-07-21
• Completion: 2021-07-21
• First posted: 2020-03-24
• Last updated: 2023-02-21

Locations

3 sites across 1 country: France