[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
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Cancer||Drug: [18F]-DPA-714 PET/CT scan||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Multicentric, open prospective study|
|Masking:||None (Open Label)|
|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|
pretherapeutic [18F]-DPA-714 PET/CT scan
Drug: [18F]-DPA-714 PET/CT scan
Pretherapeutic [18F]-DPA-714 PET/CT scan
- 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
- 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
- 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
- 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
- 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
- [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.
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
|Contact: Caroline ROUSSEAU, MD, PhDfirstname.lastname@example.org|
|Contact: Nadia FLEURY, PhDemail@example.com|
|Institut de Cacerologie de l'ouest - site Paul Papin|
|Angers, France, 49055|
|Contact: GIRAULT Sylvie, MD +33241352700 firstname.lastname@example.org|
|APHP - Hôpital Tenon|
|Paris, France, 75020|
|Contact: MONTRAVERS Françoise, MD, PhD +33156017326 email@example.com|
|Institut de cancerologie de l'Ouest|
|Saint Herblain, France, 44805|
|Contact: Caroline ROUSSEAU, MD, PhD +33240679931 firstname.lastname@example.org|
|Tours, France, 37044|
|Contact: OULDAMER Lobna, MD, PhD +33247474741 email@example.com|
|Principal Investigator:||Caroline ROUSSEAU, MD, PhD||Institut de Cancerologie de l'Ouest|