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| Name | Class |
|---|---|
| SIRIC ILIAD | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F]-DPA-714 | Experimental | pretherapeutic [18F]-DPA-714 PET/CT scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]-DPA-714 PET/CT scan | Drug | Pretherapeutic [18F]-DPA-714 PET/CT scan |
|
| 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 |
| 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 |
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Inclusion Criteria:
18 Years and older
Triple negative primary breast cancer based on immunohistochemical results as follows:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline ROUSSEAU, MD, PhD | Institut de Cancerologie de l'Ouest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APHP - Hôpital Tenon | Paris | 75020 | France | |||
| Institut de cancerologie de l'Ouest |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 4, 2026 | |
| Reset | Jun 29, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 4, 2026 | Jun 29, 2026 |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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Multicentric, open prospective study
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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 |
| Saint-Herblain |
| 44805 |
| France |
| CHU Bretonneau | Tours | 37044 | France |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |