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

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

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.

Study Overview

• Status: Completed
• Conditions: Triple Negative Breast Cancer
• Intervention / Treatment: Drug: [18F]-DPA-714 PET/CT scan

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Paris, France, 75020
    • APHP - Hôpital Tenon
  • Saint Herblain, France, 44805
    • Institut de Cancérologie de l'Ouest
  • Tours, France, 37044
    • Chu Bretonneau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [18F]-DPA-714; pretherapeutic [18F]-DPA-714 PET/CT scan	Drug: [18F]-DPA-714 PET/CT scan; Pretherapeutic [18F]-DPA-714 PET/CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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.	18 months

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Collaborators: SIRIC ILIAD
• Investigators: Principal Investigator: Caroline ROUSSEAU, MD, PhD, Institut de Cancérologie de l'Ouest

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2020
• Primary Completion (Actual): July 21, 2021
• Study Completion (Actual): July 21, 2021

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: ICO-N-2019-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No