[18F]-DPA-714 PET/CT (Positron Emission Tomography/Computerized Tomography) in Triple Negative Breast Cancers
Triple Negative Breast Cancer
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 2
- Age range
- 18 years - Not specified
- Sex eligible
- Female
- Healthy volunteers
- Not accepted
- Participants
- 13 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
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- Assignment
- Not applicable
- Masking
- No masking
[18F]-DPA-714 PET/CT
\[18F\]-DPA-714 PET/CT scan
Drug: [18F]-DPA-714
[18F]-DPA-714 DRUG
\[18F\]-DPA-714
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Number of Participants With Predominance of M2-Polarized Macrophages
Time frame: 2 months
Intratumoral macrophages were quantified by immunohistochemistry on surgical tumor specimens. CD68-positive cells were used to quantify the total macrophage population (M1 and M2 macrophages), whereas CD163-positive cells were used to identify M2-polarized macrophages. The percentage of M2 macrophages was calculated as the proportion of CD163-positive cells among all CD68-positive macrophages.
Results are presented as the number of participants whose tumors showed a predominance of M2-polarized macrophages.
Correlation Between % M2 Using CD163 and SUV Max [18F]DPA-714 PET/CT
Time frame: 2 months
The correlation between the percentage of CD163-positive M2 macrophages (determined by immunohistochemistry) and tumor SUVmax on \[18F\]DPA-714 PET/CT was assessed using Spearman's rank correlation coefficient.
Correlation Between CD68-Positive Macrophage Infiltration and Tumor SUVmax on [18F]DPA-714 PET/CT
Time frame: 2 months
The correlation between intratumoral CD68-positive macrophage infiltration (assessed by immunohistochemistry) and tumor SUVmax on \[18F\]DPA-714 PET/CT was evaluated using Spearman's rank correlation coefficient.
Secondary measures
Distribution of [18F]DPA-714 PET/CT Tumor Uptake Patterns According to TSPO Genotype (HAB = High Affinity Binder, MAB = Mixed Affinity Binder and LAB = Low Affinity Binder)
Time frame: 2 months
Tumor uptake patterns were classified as above, equal to, or below muscular background and are presented descriptively according to TSPO genotype (HAB, MAB, LAB). No formal statistical analysis was performed because of the limited sample size.
Slope of Tumor Time-Activity Curves During Early [18F]-DPA-714 PET/CT Acquisition
Time frame: 1 month
Early tumor uptake was assessed using dynamic PET/CT time-activity curves (TACs). Results are presented as the slope of tracer accumulation derived from tumor TACs. Tumors were classified relative to the contralateral pectoral muscle as above muscular, equal to muscular, or below muscular background.
Primary Tumor Detection by [18F]-DPA-714 PET/CT, 18F-FDG PET/CT, and Diffusion-Weighted Breast MRI
Time frame: 1 month
Primary tumor detection was assessed qualitatively using \[18F\]-DPA-714 PET/CT, 18F-FDG PET/CT, and diffusion-weighted breast MRI. Results are presented as the number of participants in whom the primary tumor was identified by each imaging modality.
[18F]-DPA-714 Toxicity
Time frame: 1 month
Number of patients with adverse events and serious adverse event after \[18F\]-DPA-714 administration
Tumor SUVmean During Late [18F]-DPA-714 PET/CT Acquisition
Time frame: 1 month
Late tumor uptake was assessed during the plateau phase of dynamic \[18F\]-DPA-714 PET/CT time-activity curves (TACs). Tumors were classified relative to the contralateral pectoral muscle as above muscular, equal to muscular, or below muscular background. Results are presented as median SUVmean values and ranges for each uptake pattern.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (3)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
3 locations
APHP - Hôpital TenonParis, FranceStatus unknown
Institut de cancerologie de l'OuestSaint-Herblain, FranceStatus unknown
CHU BretonneauTours, FranceStatus unknown
Study team and timeline
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Study start
- Jun 11, 2020 Actual
- Primary completion
- Jul 21, 2021 Actual
- Study completion
- Jul 21, 2021 Actual
- First posted
- Mar 24, 2020 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Pilot Feasibility Study: Inflammation and Presence of M2 Macrophages Explorations With[18F]-DPA-714 PET/CT in Triple Negative Breast Cancers
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026