Clinical trial NCT04320030: [18F]-DPA-714 PET/CT (Positron Emission Tomography/Computerized Tomography) in Triple Negative Breast Cancers
Official title: Pilot Feasibility Study: Inflammation and Presence of M2 Macrophages Explorations With[18F]-DPA-714 PET/CT in Triple Negative Breast Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Triple Negative Breast Cancer
Keywords: [18F]-DPA-714
Positron Emission Tomography/Computerized Tomography (PET/CT) scan
18 kDa Translocator Protein (TSPO)
Macrophages M1 and M2 detection
Immunohistochemical analysis
Diffusion-weighted breast Magnetic resonance imaging (MRI)
Tumor Autoradiography
Tumor molecular subtyping
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
Collaborators: name: SIRIC ILIAD
First posted: 2020-03-24
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicentric, open prospective study
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between M1/M2 macrophage polarization and [18F]DPA-714 PET/CT binding
timeFrame: 18 months
Secondary outcomes:
measure: Correlation between TSPO genotyping (HAB = High Affinity Binder, MAB = Mixed Affinity Binder and LAB = Low Affinity Binder) and [18F]DPA-714 PET/CT binding
timeFrame: 18 months
measure: Assess the value of early and late [18F]-DPA-714 PET/CT acquisitions
timeFrame: 18 months
measure: 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
timeFrame: 18 months
measure: Perform tumor molecular subtyping
timeFrame: 18 months
measure: [18F]-DPA-714 toxicity
timeFrame: 18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: APHP - Hôpital Tenon
city: Saint Herblain
country: France
facility: Institut de cancerologie de l'Ouest
city: Tours
country: France
facility: CHU Bretonneau
Study officials:
affiliation: Institut de Cancerologie de l'Ouest
name: Caroline ROUSSEAU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: