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

Phase 2CompletedNCT04320030

Institut Cancerologie de l'Ouest13 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Triple Negative Breast Cancer

Interventions

[18F]-DPA-714 PET/CT scanDRUG

Pretherapeutic \[18F\]-DPA-714 PET/CT scan

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 Years and older * Triple negative primary breast cancer based on immunohistochemical results as follows: * Estrogen receptor \< 10% * And Progesterone receptors \< 10% * And HER2 (Human Epidermal Growth Factor Receptor-2) not amplified or not overexpressed * Patient with a primary tumor eligible for primary surgery * Performance Status equal to 0 or 1 * Fertile patients must use effective contraception * Patient must be affiliated to a Social Health Insurance * Written informed consent Exclusion Criteria: * Patient with No triple negative breast cancer * Patient with inflammatory breast cancer * Patient with metastatic breast cancer * Patient receiving cancer treatments such as chemotherapy, immunotherapy, biologic response modifiers, hormonal therapy, and radiotherapy BEFORE the biopsy and PET scans are performed * Treated diabetes with fasting blood glucose \> 10 mmol/L * Patient who received antibiotics and/or steroidal and/or non-steroidal anti-inflammatory drugs within 30 days PRIOR to \[18F\]-DPA-714 PET scan * Contraindication to MRI (implants or metallic prosthesis, severe claustrophobia, pacemaker ...) * Patient deprived of liberty, under a measure of safeguard of justice, under guardianship or under the authority of a guardian * Pregnant or nursing patient * Agitation; impossibility of lying motionless for at least 1 hour, or known claustrophobia

Locations (3)

APHP - Hôpital Tenon

Paris, France

Institut de cancerologie de l'Ouest

Saint-Herblain, France

CHU Bretonneau

Tours, France

Outcomes

Primary Outcomes

Correlation between M1/M2 macrophage polarization and [18F]DPA-714 PET/CT binding

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

Secondary Outcomes

Correlation between TSPO genotyping (HAB = High Affinity Binder, MAB = Mixed Affinity Binder and LAB = Low Affinity Binder) and [18F]DPA-714 PET/CT binding

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

Assess the value of early and late [18F]-DPA-714 PET/CT acquisitions

Early and Late tumor uptake of \[18F\]-DPA-714 will be assessed by qualitative and quantitative parameters measurement

Time frame: 18 months

Evaluate the performance of the three types of imaging used in this study: [18F]-DPA-714 PET/CT (early and late), 18FDG PET/CT and diffusion-weighted breast MRI in the characterization of triple negative breast cancer

This evaluation will be done by image texture analyses

Time frame: 18 months

Perform tumor molecular subtyping

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

\[18F\]-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.

Data from ClinicalTrials.gov

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