suspected / newly diagnosed lung cancer in staging, patients already on a conventional staging diagnostic path (including FDG-PET / standard CT) MedDRA version: 20.0 Level: LLT Classification code 10025064 Term: Lung carcinoma System Organ Class: 100000004864
Conditions
Interventions
Product Name: 68Ga-FAPI-46
Product Code: [68Ga-FAPI-46]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [68Ga]Ga-FAPI-46
Current Sponsor code: [68Ga]Ga-FAPI-46
Concentration unit: MBq
Sponsors
AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with suspected / newly diagnosed lung cancer in staging, already on a conventional staging diagnostic path (including FDG-PET / standard CT); • Age =18 years • Both sexes • Signature of informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: • Pregnant women. The state of pregnancy in women of childbearing potential will be ascertained by measuring ß-hCG • Breastfeeding women • Patients in emergency situations or unable to understand and want • 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 • 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 • Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives before the study drug • Patients with severely impaired renal function • Patients with severely impaired liver function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study aims to evaluate the diagnostic performance of PET / CT with 68Ga-FAPI, in patients with staging lung cancer, in the identification of disease locations by comparing the (overall) evaluation of the 68Ga-FAPI outcome. PET / CT with histological data;Secondary Objective: Evaluate: -Diagnostic performance of PET / CT with 68Ga-FAPI experimental radiopharmaceutical, on the basis of evaluation by region, in the setting of patients referred (only by conventional staging exams) to radical surgery, subjected, according to a normal diagnostic-assistance path, to histopathological evaluation and 1 year conventional clinical diagnostic follow-up; -positivity rate and concordance of 68Ga-FAPI PET / CT with conventional staging imaging (including 18F-FDG-PET / CT and diagnostic CT), in excluded patients from radical surgery; -performance of the semi-quantitative parameters of 68Ga-FAPI uptake in the staging of lung cancer. PET / CT with 68Ga-FAPI (in terms of TNM staging) could have led to a potential, only theoretical, change in diagnostic-therapeutic management to patients.;Primary end point(s): In the primary and secondary objectives, the endpoints of the performance of PET / CT examinations with 68Ga-FAPI will be categorized as positive or negative, based on the independent evaluation of at least two nuclear doctors experts in oncology imaging. In the event of a discrepancy between the two readers or a finding of inconclusive findings, a consensus will be reached based on the opinion of a third expert nuclear doctor, also independent. The findings will be evaluated by nuclear physicians as positive for 68Ga-FAPI uptake if the SUVmax of the radiopharmaceutical in a specific VOI that fully includes the lesion is> the SUVmean of the background (surrounding tissues) which will be calculated in a VOI of 1 cm. The findings will be judged by nuclear doctors to be negative for 68Ga-FAPI uptake if they do not show uptake of the radiopharmaceutical or an upta | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): In the primary and secondary objectives, the endpoints of the performance of PET / CT examinations with 68Ga-FAPI will be categorized as positive or negative, based on the independent evaluation of at least two nuclear doctors experts in oncology imaging. In the event of a discrepancy between the two readers or a finding of inconclusive findings, a consensus will be reached based on the opinion of a third expert nuclear doctor, also independent. The findings will be evaluated by nuclear physicians as positive for 68Ga-FAPI uptake if the SUVmax of the radiopharmaceutical in a specific VOI that fully includes the lesion is> the SUVmean of the background (surrounding tissues) which will be calculated in a VOI of 1 cm. The findings will be judged by nuclear doctors to be negative for 68Ga-FAPI uptake if they do not show uptake of the radiopharmaceutical or an uptake lower than the surrounding background (SUVmax doubtful finding / SUVmean of the background =1. The results of the PET / CT survey with 68Ga-FAPI will be evaluated by nuclear doctors as VP / FP / VN / FN based on the result of the histological examination, when available; otherwise based on the comparison with conventional staging investigations (CT and PET / CT with 18F-FDG) and with the clinical-instrumental follow-up in the 12 months following the experimental investigation. Sensitivity, specificity, accuracy, PPV and NPV will be calculated on an analysis by patient and by region, to evaluate the performance of PET / CT with 68Ga-FAPI. The accuracy of PET / CT with 68Ga-FAPI will be calculated with the following statistical formula: (TRUE POSITIVE + TRUE NEGATIVE) / TOTAL PATIENTS The sensitivity of PET / CT with 68Ga-FAPI will be calculated with the following statistical formula: TRUE POSITIVE / (TRUE POSITIVE + FALSE NEGATIVE) The specificity of PET / CT with 68Ga-FAPI will be calculated with the following statistical formula: TRUE NEGATIVE / (TRUE NEGATIVE + FALSE POSITIVE) The n | — |
Countries
Italy
Contacts
Public ContactU.O. Medicina Nucleare
IRCCS AOU di Bologna, Policlinico di S.Orsola
Outcome results
None listed