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Clinical Trial · NCT06349512
68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)
Overview
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.
Sponsor
Institut Curie
Phase
N/A
Contacts
Romain-David SEBAN (PRINCIPAL_INVESTIGATOR)
Marie-Emmanuelle LEGRIER (CONTACT)
drci.promotion@curie.fr
0156245649
Sandra Nespoulous (CONTACT)
drci.promotion@curie.fr
0147111654
ClinicalTrials.gov
NCT06349512Drug / Compound
FAPI-46
Isotope(s):
GALLIUM-68
Radioisotope: Ga-68
Theranostic Role: PET Imaging
T1/2 (Half-Life): 68 minutes
Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
Range: N/A
Decay Daughters: Zn68 (Stable)
Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
Target(s):
- FAP
Ligand Class: Small Molecules
Chelator: DOTA
FDG
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Glucose Transport
Ligand Class: Small Molecules
Eligibility
Inclusion
- Patients covered by a health insurance system.
- Patients with tumor tissue available,
- Patients without distant metastasis based on staging 18F-FDG PET/CT,
- 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,
- Patient ability to comply with protocol requirements,
- Patients with measurable targets according to RECIST/PERCIST criteria,
Exclusion
- Patients with prior anti-PD(L)1 immunotherapy,
- Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons,
- Patients with any contra-indication to chemo-immunotherapy standard of care therapy, per investigator assessment,
- Pregnant and lactating women,
- Person deprived of liberty or under guardianship
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