68Ga-FAPI PET/CT in Malignant Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-88
SponsorZhongnan Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
68Ga-FAPI
Drug68Ga-FAPI was injected intravenously to each subject, and the dose is calculated according to body weight of subject (approximately 1.85-3.7MBq/kg).
PET/CT
Device68Ga-FAPI PET/CT scan were performed 20\~60 min after 68Ga-FAPI (1.85-3.7MBq/kg) injection intravenously.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: 68Ga-FAPI PET/CT in malignant tumorsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
The diagnostic sensitivity and specificity of 68Ga-FAPI PET/CT in the staging of malignant tumors
Taking the pathology or clinical follow-up as gold standard, the sensitivity and specificity of 68Ga-FAPI PET/CT in detecting malignant tumor were calculated.
Time frame
three yearsSecondary outcomes
1
Prognostic value of FAPI PET parameters in malignant tumors
Correlation 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).
Time frame
From baseline to 1 year post-treatment2
FAPI PET for therapeutic response evaluation in malignant tumors
Assessment of FAPI PET parameters, namely SUVmax, SUVmean, SUVpeak, measured in the Syngo Workstation (Siemens Healthineers), for evaluating treatment response in patients with malignant tumors.
Time frame
Within 1 week after completion of neoadjuvant or adjuvant therapy3
The connection between FAPI PET parameters and histopathological biomarkers.
Analyze 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).
Time frame
Within 4 weeks of FAPI PET scanSponsors and contacts
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Source ClinicalTrials.gov