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

Not Applicable
Completed
Conditions
Malignant Neoplasm
Interventions
Diagnostic Test: PET/CT
Registration Number
NCT06206642
Lead Sponsor
The Second Hospital of Lanzhou University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
92
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
18F-FAPI-04PET/CT18F-FAPI-04 PET-CT is injected through the patient's elbow vein without special preparation at a dose of 2.96-5.55 megabecquerels (MBq) /kg (0.08-0.15 millicurie/kg).
18F-FDGPET/CTBefore the 18F-FDG PET/CT examination, all patients should fast for at least 4-6 hours, and the fasting blood glucose should be controlled to less than 9.0mmol/L to avoid difficulties in image analysis due to poor blood glucose in patients. 18F-FDG is administered via the patient's elbow vein at a dose of 2.96-5.55 megabecquerels (MBq) /kg (0.08-0.15 millicurie/kg).
Primary Outcome Measures
NameTimeMethod
Sensitivity, specificity, accuracy, positive predictive value and negative predictive value of 18F-FAPI-04 PET/CT1 week

McNemar test

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The Second Hospital of Lanzhou University

🇨🇳

Lanzhou, Gansu, China

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