Skip to content

68Ga-FAPI PET/CT in Malignant Tumors

The Diagnostic Efficiency of 68Ga-FAPI PET/CT in Malignant Tumors

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05034146
Enrollment
500
Registered
2021-09-05
Start date
2021-02-23
Completion date
2025-12-31
Last updated
2025-06-05

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

Conditions

Fibroblast Activation Protein Inhibitor, PET/CT, Malignant Neoplasm

Brief summary

Fibroblast-activation protein (FAP) is a type Ⅱ transmembrane serine protease and is overexpressed in cancer-associated fibroblasts (CAFs). CAFs are the predominant component in the stroma of epithelial neoplasms. FAP can be detected in various of malignant neoplasms and is associated to tumor cell migration, invasion, and angiogenesis. Recently, a novel molecular probe, gallium 68-labelled FAP inhibitor (68Ga-FAPI), has been developed and used for visualization of tumor stroma by targeting FAP. Recent studies show favorable diagnosis efficiency in a variety of tumors, especially in gastrointestinal cancer, but the previous studies were all small-sample data or case reports. Therefore, further large-size research is necessary to confirm the advantages of 68Ga-FAPI in various of malignant tumors.

Detailed description

The morbidity and mortality of malignant tumors are increasing. It is one of the major diseases that affect human health. At present, the conventional imaging diagnosis methods of a variety of malignant tumors are mainly CT and MRI based on anatomical imaging. Different from traditional imaging methods to visually display the lesion, nuclear medicine molecular imaging can not only locate the tumor location, but also image the expression and activity of specific molecules and biological processes. This molecular imaging method integrating anatomy and function is a noninvasive imaging to realize the early diagnosis and differential diagnosis, curative effect evaluation and follow-up observation of a variety of tumors. Positron emission tomography/computed tomography (PET/CT) uses specific molecular probes to target tumor. It can provide detailed information about the biochemical changes of tumor tissues at the cellular and molecular levels. It has better sensitivity and specificity than conventional imaging methods. At present, the most commonly used imaging agent in clinic is 18F-fluorodeoxyglucose (18F-FDG). 18F-FDG PET/CT is a valuable imaging modality in the management of patients with malignant tumors, but it is not a specific imaging agent for tumor application. The physiological uptake of gastrointestinal tract, infected tissues, or inflammatory cells can cause high 18F-FDG uptake resulting in a significant increase of the false positive rate; in addition, some tumors including well-differentiated hepatocellular carcinoma, renal cell carcinoma, and gastric signet ring cell carcinoma have low 18F-FDG uptake resulting in a high false negative rate. Therefore, it is very important to develop new molecular probes for targeting tumor. Fibroblast-activation protein (FAP) is a type Ⅱ transmembrane serine protease and is overexpressed in cancer-associated fibroblasts (CAFs). CAFs are the predominant component in the stroma of epithelial neoplasms. FAP can be detected in various of malignant neoplasms and is associated to tumor cell migration, invasion, and angiogenesis. Recently, a novel molecular probe, gallium 68-labelled FAP inhibitor (68Ga-FAPI), has been developed and used for visualization of tumor stroma by targeting FAP. Recent studies show favorable diagnosis efficiency in a variety of tumors, especially in gastrointestinal cancer, but the previous studies were all small-sample data or case reports. Therefore, further large-size research is necessary to confirm the advantages of 68Ga-FAPI in various of malignant tumors.

Interventions

68Ga-FAPI was injected intravenously to each subject, and the dose is calculated according to body weight of subject (approximately 1.85-3.7MBq/kg).

DEVICEPET/CT

68Ga-FAPI PET/CT scan were performed 20\ 60 min after 68Ga-FAPI (1.85-3.7MBq/kg) injection intravenously.

Sponsors

Zhongnan Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Experimental: 68Ga-FAPI PET/CT Investigators select subjects from patients who have underwent whole-body 18F-FDG PET/CT scan for suspected or confirmed malignancy, or suspected recurrence and metastasis after treatment for malignant tumors, focusing on malignant tumors with low FDG uptake including glioma, hepatocellular carcinoma, renal cancer, gastrointestinal cancer, and peritoneal metastases. Then the subjects receive whole-body 68Ga-FAPI PET/CT scan with time interval of one to four week.

Eligibility

Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
Yes

Inclusion criteria

Volunteering to participate in clinical trial and sign an informed consent form Patients with suspected or confirmed malignant tumor

Exclusion criteria

Female patients plan to become pregnant within 6 months Pregnant and lactating women Patients are allergic to multiple drugs including test drug Patients have participated in other clinical trials in the past one month

Design outcomes

Primary

MeasureTime frameDescription
The diagnostic sensitivity and specificity of 68Ga-FAPI PET/CT in the staging of malignant tumorsthree yearsTaking the pathology or clinical follow-up as gold standard, the sensitivity and specificity of 68Ga-FAPI PET/CT in detecting malignant tumor were calculated.

Secondary

MeasureTime frameDescription
Prognostic value of FAPI PET parameters in malignant tumorsFrom baseline to 1 year post-treatmentCorrelation between FAPI PET parameters (SUVmax/SUVmean/SUVpeak, measured in the Syngo Workstation (Siemens Healthineers)) and long-term outcomes (e.g., progression-free survival, overall survival).
FAPI PET for therapeutic response evaluation in malignant tumorsWithin 1 week after completion of neoadjuvant or adjuvant therapyAssessment of FAPI PET parameters, namely SUVmax, SUVmean, SUVpeak, measured in the Syngo Workstation (Siemens Healthineers), for evaluating treatment response in patients with malignant tumors.
The connection between FAPI PET parameters and histopathological biomarkers.Within 4 weeks of FAPI PET scanAnalyze the correlation between FAPI PET parameters (SUVmax/SUVmean/SUVpeak, measured in the Syngo Workstation (Siemens Healthineers)) and FAP expression levels (H-score; immunohistochemistry) or immune - related biomarkers, such as PD-L1 expression (Combined Positive Score; Dako 22C3 IHC assay), CD8 expression (H-score; immunohistochemistry), Granzyme B expression (H-score; immunohistochemistry).

Countries

China

Contacts

Primary ContactYong He, MD, PhD
vincentheyong@163.com+86-27-67812698

Outcome results

None listed

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