[18F]-DPA-714 PET/CT (Positron Emission Tomography/Computerized Tomography) in Triple Negative Breast Cancers (EITHICS)

Institut Cancerologie de l'Ouest

Status and phase

Completed

Phase 2

Conditions

Triple Negative Breast Cancer

Treatments

Drug: [18F]-DPA-714 PET/CT scan

Study type

Interventional

Funder types

Other

Identifiers

NCT04320030

ICO-N-2019-04

Details and patient eligibility

About

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.

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.

Enrollment

13 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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