Role of [68Ga]Ga-FAPI PET/CT in oncological patients with doubtful or inconclusive findings at [18F]F-FDG PET/CT - FAPI-MN-2020

AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI0 个研究点目标入组 200 人开始时间: 2021年6月7日最近更新: 2021年8月17日

适应症

试验速览

暂无简介。

•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- And/or suspect primary or secondary (lymph-nodes or distant metastases) lesions in a site of phisiological FDG uptake (such as brain or liver) or in sites in which FDG has a low sensitivity (i.e. peritoneal carcinomatosis, esophageal-gastro-intestinal tract);
•- And/or low glucose metabolism tumour hystotypes (i.e. renal clear cell carcinoma, mucinous mammary tumours, well differentiated HCC);
•- And/or differential diagnosis between tumour and inflammation (i.e. determining lymph-nodes benign or malignant nature in head/neck cancers, differential diagnosis between inflammation or malignant tissue in sarcomas).
•Signed 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 140
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•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.

发起方

AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI