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

Phase 1

• Conditions: 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: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-005549-17-IT
• Lead Sponsor: AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

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- 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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified