Clinical trial · Interventional
[18F]-DPA-714 PET/CT (Positron Emission Tomography/Computerized Tomography) in Triple Negative Breast Cancers
Pilot Feasibility Study: Inflammation and Presence of M2 Macrophages Explorations With[18F]-DPA-714 PET/CT in Triple Negative Breast Cancers
NCT04320030CI-TRIAL-00064106EITHICScompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]-DPA-714 PET/CT scan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F]-DPA-714
- description
- pretherapeutic \[18F\]-DPA-714 PET/CT scan
- interventionNames
- Drug: [18F]-DPA-714 PET/CT scan
Primary outcomes (1)
- measure
- Correlation between M1/M2 macrophage polarization and [18F]DPA-714 PET/CT binding
- timeFrame
- 18 months
- 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
Secondary outcomes (5)
- measure
- Correlation between TSPO genotyping (HAB = High Affinity Binder, MAB = Mixed Affinity Binder and LAB = Low Affinity Binder) and [18F]DPA-714 PET/CT binding
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.