Status:
COMPLETED
[18F]-DPA-714 PET/CT (Positron Emission Tomography/Computerized Tomography) in Triple Negative Breast Cancers
Lead Sponsor:
Institut Cancerologie de l'Ouest
Collaborating Sponsors:
SIRIC ILIAD
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 anal...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2021
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04320030
Start Date
June 11 2020
End Date
July 21 2021
Last Update
February 21 2023
Active Locations (3)
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1
APHP - Hôpital Tenon
Paris, France, 75020
2
Institut de cancerologie de l'Ouest
Saint-Herblain, France, 44805
3
CHU Bretonneau
Tours, France, 37044