[18F]-DPA-714 PET/CT scan
DrugPretherapeutic [18F]-DPA-714 PET/CT scan
NCT Number: NCT04320030
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.
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Notify Me18 year and older
Female
Interventional
Phase 2
APHP - Hôpital Tenon, Paris, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pretherapeutic [18F]-DPA-714 PET/CT scan
Time frame: 18 months
M1/M2 macrophage polarization will be assessed by tumor immunohistochemistry analysis, [18F]DPA-714 PET/CT binding will be assessed by qualitative and images texture analysis
Time frame: 18 months
A blood sample is performed before [18F] DPA-714 PET/CT scan in order to assess the genotyping of TSPO gene at the end of study
Time frame: 18 months
Early and Late tumor uptake of [18F]-DPA-714 will be assessed by qualitative and quantitative parameters measurement
Time frame: 18 months
This evaluation will be done by image texture analyses
Time frame: 18 months
This tumor molecular subtyping will be performed on breast surgery tissue samples by immuno-histochemical analysis using a panel of antibodies
Time frame: 18 months
[18F]-DPA-714 toxicity will be assessed by vital signs monitoring within 2 hours after [18F]-DPA-714 injection. Body Temperature, Pulse Rate and Blood Pressure will be mesured within two hours after [18F]-DPA-714 injection. All adverse events due to [18F]-DPA-714 will be reported.
Institut Cancerologie de l'Ouest
Other
Pilot Feasibility Study: Inflammation and Presence of M2 Macrophages Explorations With[18F]-DPA-714 PET/CT in Triple Negative Breast Cancers
Acronym: EITHICS
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