Clinical trial · Interventional

18F-FAPI and 18F-FDG PET/CT in Patients With Various Types of Cancer

A Prospective Study on Comparison 18F-FAPI and 18F-FDG PET/CT in the Evaluation of Patients With Various Types of Cancer

NCT05485792CI-TRIAL-00060051FAPI-VTCunknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cancer	Malignant Neoplasm	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
18F-FAPI PET/CT and 18F-FDG PET/CT	Diagnostic Test	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
18F-FAPI PET/CT
description
Each subject undergone both 18F-FDG and 68Ga-FAPI PET/CT scans within 2 week
interventionNames
1. Diagnostic Test: 18F-FAPI PET/CT and 18F-FDG PET/CT

Primary outcomes (1)

measure
Maximum standardized uptake value (SUVmax)
timeFrame
30 days
description
The SUVmax of 18F-FDG PET/CT and 18F-FAPI PET/CT

Secondary outcomes (1)

measure
The target-to-background ratio (TBR)
timeFrame
30 days
description

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 90 Years

Show eligibility criteria text

Inclusion Criteria:

1. adult patients (aged 18 years or order);
2. patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include CT, MRI and pathology report);
3. patients who had scheduled both 18F-FAPI PET/CT and 18F-FDG PET/CT scans;
4. 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:

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

References

Publications (4)

DERIVEDLiang 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 40232335
DERIVEDLiang 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 39528951
DERIVEDLiang 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 39256297
DERIVEDZhang 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 37899452