Patients with Triple Negative Breast Cancer prior to surgical treatment MedDRA version: 20.0 Level: PT Classification code 10075566 Term: Triple negative breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: DPA-714
Product Code: DPA-714
Pharmaceutical Form: Concentrate for solution for injection
Sponsors
INSTITUT DE CANCEROLOGIE DE L'OUEST
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient over the age of 18 2. Patient with Triple Negative Breast Cancer defined according to the following criteria: - Estrogen receptors =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1. Patient with non-triple negative breast cancer 2. Patient with inflammatory breast cancer 3. Patient with metastatic breast cancer 4. Patient receiving anti-cancer treatments such as chemotherapy, immunotherapy, biological response modifiers, hormone therapy and radiotherapy BEFORE biopsy and PET examinations 5. Treated diabetes with fasting glucose > 10 mmol / L 6. Patient who received antibiotics and / or steroidal and / or nonsteroidal anti-inflammatory drugs within 30 days BEFORE [18F] - DPA-714 PET/CT 7. Contraindication to performing an MRI (implants or metal prosthesis, severe claustrophobia, pacemaker ...) 8. Contraindication to injection of iodinated contrast media 9. Patient deprived of liberty or placed under the authority of a guardian 10. Pregnant woman, likely to be pregnant or breastfeeding 11. Agitation, impossibility of lying motionless for at least 1 hour, or known claustrophobia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study of correlations between tumor immunohistochemical analysis (IHC) and in vivo [18F]-DPA-714 PET/TDM analysis for detection of M2 macrophages infiltrating breast cancer tumor Triple Negative;Secondary Objective: • Determine the correlation between TSPO genotyping (HAB, MAB and LAB) and [18F]DPA-714 PET/TDM binding in TN breast cancer • Assess the value of the early and late times of [18F]-DPA-714 PET/CT acquisitions. • 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 breast MRI in the characterization of Triple breast cancers. • Characterization of Triple Negative Breast Cancer. • Evaluate the potential toxicity of [18F] -DPA-714.;Primary end point(s): positive (VPP) and negative (NPV) predictive values ??of [18F] -DPA-714 PET / CT for the detection of M2 macrophage activity in the ;Timepoint(s) of evaluation of this end point: 3 month after TEP-DPA714 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Genotyping of TSPO will be done at the end of the study. The results will be compared to the [18F] DPA-714 PET / CT binding data • The comparison of early and late [18F] -DPA-714 PET / CT acquisitions will be done by comparing the qualitative and quantitative parameters of both acquisitions • Comparison of [18F] -DPA-714 PET / CT performance with 18FDG PET / CT and mammary diffusion MRI in TN breast cancer characterization with texture of images analysis • Characterization of the tumor will be achieved through the use of an antibody panel in immunohistochemistry on the specimen. • The toxicity of [18F] -DPA-714 will be ckecked by vital signs and patient monitoring for two hours following radiopharmaceutical injection. Any toxicity related to [18F] -DPA-714 will be reported. The reference NCI Common Toxicity Criteria, version 5.0 will be used (Annex 5).;Timepoint(s) of evaluation of this end point: 3 month after TEP-DPA714 | — |
Countries
France
Contacts
Public ContactPACTEAU- DRCI
INSTITUT DE CANCEROLOGIE DE L'OUEST
Outcome results
None listed