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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518765-96-00
Acronym
FAPI-MN-2020
Enrollment
200
Registered
2024-11-27
Start date
2021-06-03
Completion date
Unknown
Last updated
2025-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief summary

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

Detailed description

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.

Interventions

DRUG68Ga-FAPI-46

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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.

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026