NCT05485792

Brief Summary

FAP is overexpressed in the cancer-associated fibroblasts (CAFs) of 90% epithelial carcinomas. Currently, 68Ga-fibroblast activation protein inhibitor (FAPI) has shown promising diagnostic value in many types of tumors. However, there are currently no studies on head-to-head comparison of diagnosis value of various types of cancer in 18F-FAPI and 18F-FDG PET/CT. Therefore, we conducted a prospective study to investigate the value of 18F-FAPI PET/CT in various types of cancer, and compare it with 18F-FDG PET/CT.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Aug 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

August 3, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

August 1, 2022

Last Update Submit

August 1, 2022

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum standardized uptake value (SUVmax)

    The SUVmax of 18F-FDG PET/CT and 18F-FAPI PET/CT

    30 days

Secondary Outcomes (1)

  • The target-to-background ratio (TBR)

    30 days

Study Arms (1)

18F-FAPI PET/CT

EXPERIMENTAL

Each subject undergone both 18F-FDG and 68Ga-FAPI PET/CT scans within 2 week

Diagnostic Test: 18F-FAPI PET/CT and 18F-FDG PET/CT

Interventions

18F-FAPI PET/CT and 18F-FDG PET/CTDIAGNOSTIC_TEST

Each subject undergo both 18F-FDG and 68Ga-FAPI PET/CT scans within 1 week

18F-FAPI PET/CT

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients (aged 18 years or order);
  • patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include CT, MRI and pathology report);
  • patients who had scheduled both 18F-FAPI PET/CT and 18F-FDG PET/CT scans;
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Liang J, Weng S, Zhang J, Jiang S, Li W, Li S, Rong J, Liu H, Chen H, Liu Z, Peng H, Yan S, Zhang R, Liang SH, Zhang L. Diagnostic performance of [18F]FAPI-04 PET/CT in suspected recurrent hepatocellular carcinoma: prospective comparison with contrast-enhanced CT/MRI. Eur J Nucl Med Mol Imaging. 2025 Sep;52(11):3951-3962. doi: 10.1007/s00259-025-07273-4. Epub 2025 Apr 15.

    PMID: 40232335DERIVED

  • Liang Z, Peng H, Li W, Liu Z. Head-to-head study of [18F]FAPI-04 PET/CT and [18F]FDG PET/CT for non-invasive assessment of liver cancer and its immunohistochemical markers. BMC Cancer. 2024 Nov 11;24(1):1378. doi: 10.1186/s12885-024-13153-1.

    PMID: 39528951DERIVED

  • Liang J, Jiang S, Song J, Chen D, Weng S, Li S, Peng H, Liu Z, Zhang J, Chen Y, Rao S, Chen H, Zhang R, Liu H, Zhang L. Role of [18F]FAPI-04 in staging and therapeutic management of intrahepatic cholangiocarcinoma: prospective comparison with [18F]FDG PET/CT. EJNMMI Res. 2024 Sep 11;14(1):81. doi: 10.1186/s13550-024-01145-y.

    PMID: 39256297DERIVED

  • Zhang J, Jiang S, Li M, Xue H, Zhong X, Li S, Peng H, Liang J, Liu Z, Rao S, Chen H, Cao Z, Gong Y, Chen G, Zhang R, Zhang L. Head-to-head comparison of 18F-FAPI and 18F-FDG PET/CT in staging and therapeutic management of hepatocellular carcinoma. Cancer Imaging. 2023 Oct 30;23(1):106. doi: 10.1186/s40644-023-00626-y.

    PMID: 37899452DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Rusen Zhang, MD

    Affiliated Cancer Hospital & Institute of Guangzhou Medical University

    STUDY DIRECTOR

Central Study Contacts

Rusen Zhang, MD

CONTACT

0086-13642328295zhangrusen2015@163.com

Linqi Zhang, PhD

CONTACT

0086-18825135918zhanglinqi0909@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Subjects with various types of cancer undergo contemporaneous 18F-FAPI and 18F-FDG PET/CT either for an initial assessment or for recurrence detection.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 3, 2022

Study Start

August 1, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2023

Last Updated

August 3, 2022

Record last verified: 2022-07