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Completed

NCT Number: NCT04320030

[18F]-DPA-714 PET/CT (Positron Emission Tomography/Computerized Tomography) 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

APHP - Hôpital Tenon, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Primary outcomes

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

    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

Secondary outcomes

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

    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

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

    Time frame: 18 months

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

  3. 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

    Time frame: 18 months

    This evaluation will be done by image texture analyses

  4. Perform tumor molecular subtyping

    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

  5. [18F]-DPA-714 toxicity

    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.

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Collaborators

  • SIRIC ILIAD

Registry information

Official study title

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

Acronym: EITHICS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 24, 2020
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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