oncological disease suspicion/ new diagnosis or with a previously treated tumour, with an inconclusive or equivocal findings after the standard clinical/diagnostic flow chart: [18F]F-FDG PET/CT imaging not able to solve the clinical doubt MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: [68Ga]Ga-FAPI-46
Product Code: [68GaGa-FAPI-46]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [68Ga]Ga-FAPI-46
Current Sponsor code: [68Ga]Ga-FAPI-46
Concentration uni
Sponsors
AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age =18 years old • Both sexes • 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=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: • Pregnant women. The state of pregnancy in women of childbearing potential will be ascertained by measuring serum 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 impaired renal function; • Patients with impaired liver function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study aims to evaluate the 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 path, the diagnostic doubt remains: examination PET / CT with 18F-FDG resulted doubtful for the presence of oncological disease or inconclusive in satisfying this diagnostic question.;Secondary Objective: A second objective is to evaluate the accuracy, sensitivity and specificity of PET / CT with 68Ga-FAPI compared to PET / CT with 18F-FDG (standard tracer currently used in various cancer settings).;Primary end point(s): 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 findings will be evaluated as positive (PET FAPI +) 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 10 min after administration. The findings will be judged negative (PET FAPI-) 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 as TRUE POSITIVE / FALSE POSITIVE / TRUE NEGATIVE and FALSE NEGATIVE based on the result of the histological examination if available otherwise based on the comparison with the follow-up investigations over 12 months following the experimental investigation. The accuracy of PET / CT with 68Ga-FAPI will be calculated with the following statistical formula: (TRUE POSITIVE + TRUE NEGATIVE) / TOTAL PATI | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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. The findings will be evaluated as positive (PET FAPI +) 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 10 min after administration. The findings will be judged negative (PET FAPI-) 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. Findings will be evaluated as positive (PET FDG +) if the radiopharmaceutical SUVmax in a VOI that fully includes the lesion is> 2. Findings will be evaluated as positive (PET FDG-) if the radiopharmaceutical SUVmax in a VOI that fully includes the lesion is = 2. The results of PET / CT investigations with 68Ga-FAPI and 18F-FDG will be evaluated as TRUE POSITIVE / FALSE POSITIVE / TRUE NEGATIVE and FALSE NEGATIVE based on the result of the histological examination if available otherwise based on the comparison with the follow up investigations in the 12 months following the experimental investigation. The accuracy of PET / CT with 68Ga-FAPI and with 18F-FDG will be calculated with the following statistical formula: (TRUE POSITIVE + TRUE NEGATIVE) / TOTAL PATIENTS The sensitivity of PET / CT with 68Ga-FAPI and with 18F-FDG will be calculated with the following statistical formula: TRUE POSITIVE / (TRUE POSITIVE + FALSE NEGATIVE) The specificity of PET / CT with 68Ga-FAPI and with 18F-FDG will be calculated with the fol | — |
Countries
Italy
Contacts
Public ContactU.O. Medicina Nucleare
AOU di Bologna Policlinico S.Orsola
Outcome results
None listed