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RecruitingNCT04416165Updated Aug 8, 2023

Comparison of FDG and FAPI in Patients With Various Types of Cancer

An interventional study of 18F-FDG and 68Ga-DOTA-FAPI -04 PET/CT in Tumor, Solid, Positron-Emission Tomography and Metastasis, sponsored by The First Affiliated Hospital of Xiamen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-08-08.

Sponsored by The First Affiliated Hospital of Xiamen University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Oct 2019, registered Jun 2020).
  • Started Oct 2019; still recruiting 6 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
3,000
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study summary

To evaluate the potential usefulness of 68Ga-DOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, compared with 18F-FDG PET/CT.

Read the detailed description

Subjects with various types of cancer underwent contemporaneous 68Ga-DOTA-FAPI-04 and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT were calculated and compared to evaluate the diagnostic efficacy.

02

Conditions studied

  • Tumor, Solid
  • Positron-Emission Tomography
  • Metastasis

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Keywords

  • Positron-Emission Tomography
  • Tumor, Solid
  • Diagnosis
  • Metastasis
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

The First Affiliated Hospital of Xiamen University is the lead sponsor of 115 studies on the registry; 76 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

  • (i) adult patients (aged 18 years or order); (ii) patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report); (iii) patients who had scheduled both 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT scans; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion criteria

Exclusion Criteria:

  • (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3,000 participants (estimated)

Study arms

  • Experimental
    Experimental: 68Ga-DOTA-FAPI-04

    Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI-04, and undergo PET/CT imaging within the specified time.

    Diagnostic Test: 18F-FDG and 68Ga-DOTA-FAPI -04 PET/CT

Interventions

  • Diagnostic test18F-FDG and 68Ga-DOTA-FAPI -04 PET/CT

    Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI-04, and undergo PET/CT imaging within the specified time.

06

What researchers measure

Primary outcomes

  1. SUV

    Standardized uptake value (SUV) of 18F/ 68Ga-DOTA-FAPI-04 for each target lesion of subject or suspected primary tumor or/and metastasis.

    Time frame: 30 days

Secondary outcomes

  1. Diagnostic efficacy

    The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT were calculated and compared to evaluate the diagnostic efficacy.

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
  • First affiliated hospital of xiamen university
    XiaMen, Fujian 0086-361000, China
    Recruiting
08

References and documents

Publications

  • Guo W, Pang Y, Yao L, Zhao L, Fan C, Ke J, Guo P, Hao B, Fu H, Xie C, Lin Q, Wu H, Sun L, Chen H. Imaging fibroblast activation protein in liver cancer: a single-center post hoc retrospective analysis to compare [68Ga]Ga-FAPI-04 PET/CT versus MRI and [18F]-FDG PET/CT. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1604-1617. doi: 10.1007/s00259-020-05095-0. Epub 2020 Nov 11. PubMed 33179149 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04416165
Lead sponsor
The First Affiliated Hospital of Xiamen University
Responsible party
Sponsor
First posted
Jun 4, 2020
Start date
Oct 20, 2019
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Aug 8, 2023

Study contacts

Hua Wu, PhD
Contact
wuhua1025@163.com
86 0592-2137166
Haojun Chen, PhD
Contact
leochen0821@foxmail.com
86 0592-2137166

Oversight

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

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