Comparing 18F-FAPI-04 and 18F-FDG PET/CT in Cancer Detection

Evaluation of a Novel Targeted Molecular Probe 18F-FAPI-04 PET/CT for Various Malignant Tumors: Comparison With 18F-FDG PET/CT

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06206642

Enrollment

Registered

2024-01-16

Start date

2022-04-01

Completion date

2023-12-31

Last updated

2024-01-16

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

Conditions

Malignant Neoplasm

Keywords

18F-FDG, 18F-FAPI, PET/CT

Brief summary

Evaluating fluoro-18-fibroblast activation protein inhibitor-04 positron emission computed tomography's diagnostic efficacy for primary malignancies versus 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose.

Detailed description

In recent years, radionuclide labeled fibroblast activating protein inhibitors (FAPIs) have gradually become a new strategy for targeted diagnosis and therapy. In this study, radionuclide 18F was used to label FAPI, and the imaging value of FAPI was compared with that of common developer 18F-FDG. To evaluate the diagnostic value of 18F-FAPI-04 PET/CT in various malignant tumors.

Interventions

DIAGNOSTIC_TESTPET/CT

Low-dose CT images were first collected during scanning. The tube voltage was 120kilovolt, the tube current was 50-220Milliampere and the layer thickness was 3.75mm.

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

Adult (≥18 years old); PET/CT examination is required after evaluation by oncologist. Healthy persons who volunteer for PET/CT scans; Can cooperate to complete the inspection process; I or family members, legal representatives agree to participate in the study and can sign the informed consent in person.

Exclusion criteria

The patient has a serious underlying disease or mental illness and is unable to cooperate with the PET/CT examination; Have received systematic chemotherapy; Previous history of primary tumor; Pregnancy; I or family members, legal representatives are unable or unwilling to provide written informed consent.

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity, specificity, accuracy, positive predictive value and negative predictive value of 18F-FAPI-04 PET/CT	1 week	McNemar test

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026