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

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ClinicalTrials.gov Identifier: NCT04320030
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
SIRIC ILIAD : regional consortium led by the health cooperation consortium
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

Study Description
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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.

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Drug: [18F]-DPA-714 PET/CT scan Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Multicentric, open prospective study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Feasibility Study: Inflammation and Presence of M2 Macrophages Explorations With[18F]-DPA-714 PET/CT in Triple Negative Breast Cancers
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320030


Contacts
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Contact: Caroline ROUSSEAU, MD, PhD +33240679931 caroline.rousseau@ico.unicancer.fr
Contact: Nadia FLEURY, PhD +33240679826 nadia.fleury@ico.unicancer.fr

Locations
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France
Institut de Cacerologie de l'ouest - site Paul Papin
Angers, France, 49055
Contact: GIRAULT Sylvie, MD    +33241352700    sylvie.girault@ico.unicancer.fr   
APHP - Hôpital Tenon
Paris, France, 75020
Contact: MONTRAVERS Françoise, MD, PhD    +33156017326    francoise.montravers@aphp.fr   
Institut de cancerologie de l'Ouest
Saint Herblain, France, 44805
Contact: Caroline ROUSSEAU, MD, PhD    +33240679931    caroline.rousseau@ico.unicancer.fr   
CHU Bretonneau
Tours, France, 37044
Contact: OULDAMER Lobna, MD, PhD    +33247474741    lobna.ouldamer@univ-tours.fr   
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
SIRIC ILIAD : regional consortium led by the health cooperation consortium
Investigators
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Principal Investigator: Caroline ROUSSEAU, MD, PhD Institut de Cancerologie de l'Ouest
More Information
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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT04320030    
Other Study ID Numbers: ICO-N-2019-04
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Cancerologie de l'Ouest:
[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:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases