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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05485792
Acronym
FAPI-VTC
Enrollment
200
Registered
2022-08-03
Start date
2022-08-01
Completion date
2023-12-30
Last updated
2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Detailed description

Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fibroblast membranes. FAP is overexpressed in the cancer-associated fibroblasts (CAFs) of 90% epithelial carcinomas, including primary and metastatic liver cancer. Therefore, FAP-targeted radiopharmaceuticals can be considered a promising approach for the visualization of CAFs. CAFs are crucial component of tumor stroma, promote the growth of cancer cells and are associated with poor prognosis. Currently, Gallium 68 (68Ga)-fibroblast activation protein inhibitor (FAPI) has shown promising diagnostic value in many types of tumors, including lung cancer, gastric carcinomas, peritoneal carcinomas. 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.

Interventions

DIAGNOSTIC_TEST18F-FAPI PET/CT and 18F-FDG PET/CT

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

Sponsors

Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Subjects with various types of cancer undergo contemporaneous 18F-FAPI and 18F-FDG PET/CT either for an initial assessment or for recurrence detection.

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Maximum standardized uptake value (SUVmax)30 daysThe SUVmax of 18F-FDG PET/CT and 18F-FAPI PET/CT

Secondary

MeasureTime frameDescription
The target-to-background ratio (TBR)30 daysThe target-to-background ratio (TBR) was calculated by dividing the SUVmax of the lesion by the SUVmax of soft tissue background

Contacts

Primary ContactRusen Zhang, MD
zhangrusen2015@163.com0086-13642328295
Backup ContactLinqi Zhang, PhD
zhanglinqi0909@163.com0086-18825135918

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026