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

NCT ID: NCT04320030

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-11
• Study Completion Date: 2021-07-21

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 analysis) in patients with operable triple negative breast cancer.

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 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.

Conditions

Triple Negative Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[18F]-DPA-714

pretherapeutic \[18F\]-DPA-714 PET/CT scan

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Pretherapeutic \[18F\]-DPA-714 PET/CT scan

Interventions

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

Pretherapeutic \[18F\]-DPA-714 PET/CT scan

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

SIRIC ILIAD

UNKNOWN

Sponsor Role: collaborator

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline ROUSSEAU, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancerologie de l'Ouest

Locations

APHP - Hôpital Tenon

Paris, , France

Institut de cancerologie de l'Ouest

Saint-Herblain, , France

CHU Bretonneau

Tours, , France

Countries

France

Other Identifiers

ICO-N-2019-04

Identifier Type: -

Identifier Source: org_study_id