(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-CYANO-4,4-DIFLUOROPYRROLIDIN-1-YL)-2-OXOETHYLCARBAMOYL)-QUINOLIN-6-YL)(METHYL)AMINO)-PROPYL)PIPERAZIN-1-YL)-2-OXOETHYL)-68GA-[1,4,7,10]-TETRAAZACYCLODODECANE-1,4,7-TRIYL)TRIACETATE for Neoplasm (suspected or previously treated)

Inclusion criteria

• {"criterion_text":"- • Age =18 years old"}
• {"criterion_text":"- • Both sexes"}
• {"criterion_text":"- • Patients with suspected or newly diagnosed or previously treated neoplasm (prior therapies of at least 3 months), in the presence of inconclusive FDG findings such as: - Suspect primary or secondary (lymph-nodes or distant metastases) lesions with absent/faint FDG uptake (SUVmax"}

Exclusion criteria

• {"criterion_text":"- • Pregnant women. The state of pregnancy in women of childbearing potential will be ascertained by measuring serum ß-hCG."}
• {"criterion_text":"- • Breastfeeding women"}
• {"criterion_text":"- • Patients in emergency situations or unable to understand and want"}
• {"criterion_text":"- • History of allergic reactions or hypersensitivity to the active substance, to any of the excipients, or to any of the components of the radiolabelled radiopharmaceutical"}
• {"criterion_text":"- • Contraindication to PET / CT examination for patients unable to perform PET due to weight, claustrophobia or the inability to remain still for the duration of the examination"}
• {"criterion_text":"- • Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives before the study drug"}
• {"criterion_text":"- • Patients with impaired renal function;"}
• {"criterion_text":"- • Patients with impaired liver function."}

Primary endpoints

• {"endpoint_text":"- Accuracy of PET / CT with 68Ga-FAPI in detecting the presence of disease in patients for whom, upon completion of the clinical and instrumental diagnostic procedures required by their normal care pathway, the diagnostic doubt remains: PET / CT examination with 18F-FDG result doubt for the presence of oncological disease or inconclusive in satisfying this diagnostic question.The accuracy of PET / CT with 68Ga-FAPI will be calculated with the following statistical formula: (TRUE POSITIVE+TRUE NE","definition_or_measurement_approach":"The accuracy of PET/CT with 68Ga-FAPI will be calculated with the following statistical formula: (TRUE POSITIVE+TRUE NE (text truncated in source))."}

Secondary endpoints

• {"endpoint_text":"- Evaluation of the accuracy, sensitivity and specificity of PET / CT with 68Ga-FAPI and PET / CT with 18F-FDG in detecting the presence of disease in patients for whom, upon completion of the clinical and instrumental diagnostic procedures required by their normal course care, the diagnostic doubt remains: PET / CT examination with 18F-FDG resulted in doubt due to the presence of oncological disease or inconclusive in satisfying this diagnostic question.","definition_or_measurement_approach":"Assessment of accuracy, sensitivity and specificity of PET/CT with 68Ga-FAPI compared to PET/CT with 18F-FDG as described in the endpoint text; no additional statistical details provided in the available record."}

Italy

Earliest CTIS Part Ii Submission Date

10-10-2024

Latest Decision Or Authorization Date

12-05-2025

Processing Time Days

214

Number Of Sites

1

Number Of Participants

200

Primary sponsor

Full Name

Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"IRCCS AOUBO Policlinico di S.Orsola (internal funding, donation SOFIE)","duties_or_roles":"Source of monetary support/funding","organisation_type":""}