NCT04320030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 11, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2021

Completed
Last Updated

February 21, 2023

Status Verified

August 1, 2022

Enrollment Period

1.1 years

First QC Date

February 20, 2020

Last Update Submit

February 20, 2023

Conditions

Triple Negative Breast Cancer

Keywords

[18F]-DPA-714Positron Emission Tomography/Computerized Tomography (PET/CT) scan18 kDa Translocator Protein (TSPO)Macrophages M1 and M2 detectionImmunohistochemical analysisDiffusion-weighted breast Magnetic resonance imaging (MRI)Tumor AutoradiographyTumor molecular subtyping

Outcome Measures

Primary Outcomes (1)

  • Correlation between M1/M2 macrophage polarization and [18F]DPA-714 PET/CT binding

    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

    18 months

Secondary Outcomes (5)

  • Correlation between TSPO genotyping (HAB = High Affinity Binder, MAB = Mixed Affinity Binder and LAB = Low Affinity Binder) and [18F]DPA-714 PET/CT binding

    18 months

  • Assess the value of early and late [18F]-DPA-714 PET/CT acquisitions

    18 months

  • Evaluate the performance of the three types of imaging used in this study: [18F]-DPA-714 PET/CT (early and late), 18FDG PET/CT and diffusion-weighted breast MRI in the characterization of triple negative breast cancer

    18 months

  • Perform tumor molecular subtyping

    18 months

  • [18F]-DPA-714 toxicity

    18 months

Study Arms (1)

[18F]-DPA-714

EXPERIMENTAL

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

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

Interventions

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

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

[18F]-DPA-714

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

APHP - Hôpital Tenon

Paris, 75020, France

Location

Institut de cancerologie de l'Ouest

Saint-Herblain, 44805, France

Location

CHU Bretonneau

Tours, 37044, France

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Caroline ROUSSEAU, MD, PhD

    Institut de Cancerologie de l'Ouest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Multicentric, open prospective study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

March 24, 2020

Study Start

June 11, 2020

Primary Completion

July 21, 2021

Study Completion

July 21, 2021

Last Updated

February 21, 2023

Record last verified: 2022-08

Locations

FR(3)