Back to results[18F]-DPA-714 PET/CT (Positron Emission Tomography/Computerized Tomography) in Triple Negative Breast Cancers (EITHICS)
Primary Purpose
Triple Negative Breast Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
[18F]-DPA-714 PET/CT scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Triple Negative Breast Cancer focused on measuring [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
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
Sites / Locations
- APHP - Hôpital Tenon
- Institut de cancerologie de l'Ouest
- CHU Bretonneau
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[18F]-DPA-714
Arm Description
pretherapeutic [18F]-DPA-714 PET/CT scan
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
[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.
Full Information
NCT ID
NCT04320030
First Posted
February 20, 2020
Last Updated
February 20, 2023
Sponsor
Institut Cancerologie de l'Ouest
Collaborators
SIRIC ILIAD
1. Study Identification
Unique Protocol Identification Number
NCT04320030
Brief Title
[18F]-DPA-714 PET/CT (Positron Emission Tomography/Computerized Tomography) in Triple Negative Breast Cancers
Acronym
EITHICS
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 11, 2020 (Actual)
Primary Completion Date
July 21, 2021 (Actual)
Study Completion Date
July 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest
Collaborators
SIRIC ILIAD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Multicentric, open prospective study
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[18F]-DPA-714
Arm Type
Experimental
Arm Description
pretherapeutic [18F]-DPA-714 PET/CT scan
Intervention Type
Drug
Intervention Name(s)
[18F]-DPA-714 PET/CT scan
Intervention Description
Pretherapeutic [18F]-DPA-714 PET/CT scan
Primary Outcome Measure Information:
Title
Correlation between M1/M2 macrophage polarization and [18F]DPA-714 PET/CT binding
Description
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 Outcome Measure Information:
Title
Correlation between TSPO genotyping (HAB = High Affinity Binder, MAB = Mixed Affinity Binder and LAB = Low Affinity Binder) and [18F]DPA-714 PET/CT binding
Description
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
Title
Assess the value of early and late [18F]-DPA-714 PET/CT acquisitions
Description
Early and Late tumor uptake of [18F]-DPA-714 will be assessed by qualitative and quantitative parameters measurement
Time Frame
18 months
Title
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
Description
This evaluation will be done by image texture analyses
Time Frame
18 months
Title
Perform tumor molecular subtyping
Description
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
Title
[18F]-DPA-714 toxicity
Description
[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.
Time Frame
18 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline ROUSSEAU, MD, PhD
Organizational Affiliation
Institut de Cancerologie de l'Ouest
Official's Role
Principal Investigator
Facility Information:
Facility Name
APHP - Hôpital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Institut de cancerologie de l'Ouest
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
CHU Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
12. IPD Sharing Statement
Learn more about this trial
[18F]-DPA-714 PET/CT (Positron Emission Tomography/Computerized Tomography) in Triple Negative Breast Cancers
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