Triple Negative Breast CancerPhase 2EITHICSNCT04320030
[18F]-DPA-714 PET/CT (Positron Emission Tomography/Computerized Tomography) in Triple Negative Breast Cancers
A Phase 2 study testing [18F]-DPA-714 PET/CT scan in people with Triple Negative Breast Cancer, run by Institut Cancerologie de l'Ouest at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- [18F]-DPA-714 PET/CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesFrance
- Study dates
- 11 Jun 2020to 21 Jul 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
APHP - Hôpital Tenon
Paris, 75020
Institut de cancerologie de l'Ouest
Saint-Herblain, 44805
CHU Bretonneau
Tours, 37044
About this study
Official title: Pilot Feasibility Study: Inflammation and Presence of M2 Macrophages Explorations With[18F]-DPA-714 PET/CT in Triple Negative Breast Cancers
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 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
- Being tested
- [18F]-DPA-714 PET/CT scan
- Keywords
- [18F]-DPA-714, Positron Emission Tomography/Computerized Tomography (PET/CT) scan, 18 kDa Translocator Protein (TSPO), Macrophages M1 and M2 detection, Immunohistochemical analysis, Diffusion-weighted breast Magnetic resonance imaging (MRI), Tumor Autoradiography, Tumor molecular subtyping
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-DPA-714 PET/CT scanDrug
Pretherapeutic [18F]-DPA-714 PET/CT scan
| Study group | Role | What they receive |
|---|---|---|
| [18F]-DPA-714 | Experimental | pretherapeutic [18F]-DPA-714 PET/CT scan Receives: Drug: [18F]-DPA-714 PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
A blood sample is performed before [18F] DPA-714 PET/CT scan in order to assess the genotyping of TSPO gene at the end of study
Measured: 18 months
Assess the value of early and late [18F]-DPA-714 PET/CT acquisitions
Early and Late tumor uptake of [18F]-DPA-714 will be assessed by qualitative and quantitative parameters measurement
Measured: 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
This evaluation will be done by image texture analyses
Measured: 18 months
Perform tumor molecular subtyping
This tumor molecular subtyping will be performed on breast surgery tissue samples by immuno-histochemical analysis using a panel of antibodies
Measured: 18 months
[18F]-DPA-714 toxicity
[18F]-DPA-714 toxicity will be assessed by vital signs monitoring within 2 hours after [18F]-DPA-714 injection. Body Temperature, Pulse Rate and Blood Pressure will be mesured within two hours after [18F]-DPA-714 injection. All adverse events due to [18F]-DPA-714 will be reported.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start11 Jun 2020
- Primary completion21 Jul 2021
- Study completion21 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicentric, open prospective study
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- SIRIC ILIAD
- Responsible party
- Sponsor
- Investigators
- Caroline ROUSSEAU, MD, PhD, Principal investigator, Institut de Cancerologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320030
- Sponsor's protocol ID
- ICO-N-2019-04
- Acronym
- EITHICS
- Status last verified
- Aug 2022
- First submitted
- 20 Feb 2020
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study: Inflammation and Presence of M2 Macrophages Explorations With[18F]-DPA-714 PET/CT in Triple Negative Breast Cancers
- ClinicalTrials.gov ID
- NCT04320030
- Acronym / sponsor ID
- EITHICS / ICO-N-2019-04
- Conditions
- Triple Negative Breast Cancer
- Keywords
- [18F]-DPA-714, Positron Emission Tomography/Computerized Tomography (PET/CT) scan, 18 kDa Translocator Protein (TSPO), Macrophages M1 and M2 detection, Immunohistochemical analysis, Diffusion-weighted breast Magnetic resonance imaging (MRI), Tumor Autoradiography, Tumor molecular subtyping
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- SIRIC ILIAD
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicentric, open prospective study
| Arm | Type | Receives |
|---|---|---|
| [18F]-DPA-714 | Experimental | Drug: [18F]-DPA-714 PET/CT scanpretherapeutic [18F]-DPA-714 PET/CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 Years and older
- Triple negative primary breast cancer based on immunohistochemical results as follows:
- Patient with a primary tumor eligible for primary surgery
- Performance Status equal to 0 or 1
- Fertile patients must use effective contraception
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]-DPA-714 PET/CT scanPretherapeutic [18F]-DPA-714 PET/CT scan | Drug | [18F]-DPA-714 |
Primary outcome
Correlation between M1/M2 macrophage polarization and [18F]DPA-714 PET/CT binding
Time frame: 18 months
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
5 secondary outcomes
Correlation between TSPO genotyping (HAB = High Affinity Binder, MAB = Mixed Affinity Binder and LAB = Low Affinity Binder) and [18F]DPA-714 PET/CT binding
Time frame: 18 months
Assess the value of early and late [18F]-DPA-714 PET/CT acquisitions
Time frame: 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
Time frame: 18 months
Perform tumor molecular subtyping
Time frame: 18 months
[18F]-DPA-714 toxicity
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline ROUSSEAU, MD, PhD principal investigator
Institut de Cancerologie de l'Ouest
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [18F]-DPA-714 PET/CT scan in people with Triple Negative Breast Cancer, run by Institut Cancerologie de l'Ouest at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between M1/M2 macrophage polarization and [18F]DPA-714 PET/CT binding (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.