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CompletedNCT06206642Updated Jan 16, 2024

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

An interventional study of PET/CT in Malignant Neoplasm, sponsored by Lanzhou University Second Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-01-16.

Sponsored by Lanzhou University Second Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Apr 2022, registered Jan 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Malignant Neoplasm

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Keywords

  • 18F-FDG
  • 18F-FAPI
  • PET/CT
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's enrollment of 92 is above the median of 50 across 7,250 interventional studies indexed under Neoplasms.

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Lead sponsor

Lanzhou University Second Hospital is the lead sponsor of 12 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    18F-FAPI-04

    18F-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).

    Diagnostic Test: PET/CT

  • Experimental
    18F-FDG

    Before 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).

    Diagnostic Test: PET/CT

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.

06

What researchers measure

Primary outcomes

  1. Sensitivity, specificity, accuracy, positive predictive value and negative predictive value of 18F-FAPI-04 PET/CT

    McNemar test

    Time frame: 1 week

07

Study locations

1 site
  • The Second Hospital of Lanzhou University
    Lanzhou, Gansu 730030, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06206642
Lead sponsor
Lanzhou University Second Hospital
Responsible party
Xiaoxue Tian (Attending physician, Lanzhou University Second Hospital) — Principal investigator
First posted
Jan 16, 2024
Start date
Apr 1, 2022
Primary completion
Oct 31, 2023
Completion
Dec 31, 2023
Last update
Jan 16, 2024

Study contacts

Liu Jiangyan
study director · Lanzhou University Second Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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