Radiological Prediction of Response to Neoadjuvant Chemoimmunotherapy for Triple-negative Breast Cancer
Recruiting · NCT06879704 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Henri Becquerel
View the official record on ClinicalTrials.gov →Interventions studied
Imaging assessment
What this trial is about
The aim of our study is to find the best imaging technique, alone or in combination, that can best predict a complete response (absence of tumour cells). It also seems important to identify blood markers able to predict which patients will benefit most from treatment, with a view to personalising them, or which patients will be most at risk of toxicities, particularly related to immunotherapy, with a view to personalising monitoring.
Who can take part
Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Signed informed consent
- Patient with histologically proven TNBC
- Indication for neo-adjuvant chemo-immunotherapy treatment
- Age between 18 and 75
- Affiliated or beneficiary of a social protection scheme
Exclusion criteria
- Pregnant or breast-feeding women
- Contraindication to immunotherapy
- Inflammatory breast cancer (T4d)
- Metastatic patients
- Allergies to iodine or gadolinium
- Patient with an augmentation prosthesis (for angiography/mammography)
- Claustrophobic patients
- Renal contraindication to contrast products according to SFR-CIRTACI
- Ferromagnetic material
- Uncontrolled diabetes (blood glucose \>10 mmol/L)
- Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problems, etc.).
- Patient under guardianship, curatorship or safeguard of justice
Where it is running
1 location listed.
- Centre Henri Becquerel - Rouen, France