68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)
Recruiting · NCT06349512 · Interventional (participants receive a specific treatment) · Lead sponsor: Institut Curie
View the official record on ClinicalTrials.gov →Interventions studied
68Ga-FAPI-46 PET/CT imaging
What this trial is about
Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC.
Who can take part
Age range
18 Years and older
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
- Female with age ≥ 18 years,
- Patients with previously untreated, non-metastatic, centrally confirmed TNBC for whom a neoadjuvant treatment with chemotherapy + pembrolizumab is the recommended option as standard of care,
- Patients with measurable targets according to RECIST/PERCIST criteria,
- Patients without distant metastasis based on staging 18F-FDG PET/CT,
- Patients with tumor tissue available,
- Patients who provided a signed written informed consent,
- Patient ability to comply with protocol requirements,
- Patients covered by a health insurance system.
Exclusion criteria
- Pregnant and lactating women,
- Patients with prior anti-PD(L)1 immunotherapy,
- Patients with any contra-indication to chemo-immunotherapy standard of care therapy, per investigator assessment,
- Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent,
- Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons,
- Person deprived of liberty or under guardianship
Where it is running
6 locations listed.
- Hôpital Privé d'Antony - Antony, France
- Institut Curie -site Paris - Paris, France
- GH Diaconesses Croix Saint-Simon - Paris, France
- Institut Curie -site St Cloud - Saint-Cloud, France
- HIA Begin - Saint-Mandé, France
- Hôpital FOCH - Suresnes, France