Integrin αvβ6-targeted PET in Malignant Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorZhongnan Hospital
About this trial
Malignant tumors are a significant health threat with high incidence and mortality rates, and molecular imaging is crucial for early diagnosis, staging, prognosis evaluation, and therapeutic efficacy assessment. 18F-FDG PET imaging is widely used, but has limitations. Integrin αvβ6 is a promising target for tumor-targeted imaging, as it is only expressed in cancerous or reconstructed epithelial cells. A new PET probe, 68Ga-Trivehexin, targeting integrin αvβ6 has been developed with better affinity and selectivity than previous probes. Clinical data supports its safety and metabolic stability, and future research will explore its diagnostic and staging value in different types of tumors, providing a new and precise evaluation method for malignant tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants with newly diagnosed malignant tumor confirmed by pathology or suspected lung cancer;
Age ≥18 years, regardless of gender;
No prior anti-tumor therapy (e.g., chemotherapy, radiotherapy, targeted therapy, or immunotherapy) before PET/CT;
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1;
Disqualifiers
Known allergy to injection or its excipients;
Severe liver or renal dysfunction;
Claustrophobia or other psychiatric disorders;
History of other malignant tumors;
Trial population
in-patinets
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
PET/CT scans
Diagnostic testDiagnostic Test: For 68Ga-Trivehexin PET/CT, no special preparation was required. Approximately 50 min after an i.v. administration of \[68Ga\]Ga-Trivehexin with a dose of 1.85-2.22 MBq/kg, and the PET acquisition time was 2.5 min per bed.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Integrin αvβ6-targeted PET in malignant tumors1 intervention
Trial outcomes
Primary outcomes
1
The diagnostic sensitivity and specificity of 68Ga-Integrin αvβ6 PET/CT in the staging of malignant tumors
The diagnostic performance of \[68Ga\]Ga-Trivehexin PET/CT and \[18F\]-FDG PET/CT for initial staging will be evaluated and compared using histopathological findings or typical imaging features as reference standard.
Time frame
2 yearsSecondary outcomes
1
Comparison of primary and metastatic lesions between [68Ga]Ga-Trivehexin PET/CT and [18F]FDG PET/CT
1. Comparison of tracer uptake values of primary and metastatic lesions between \[68Ga\]Ga-Trivehexin PET/CT and \[18F\]FDG PET/CT. 2. Evaluation of the correlation between \[68Ga\]Ga-Trivehexin-derived parameters and tumor integrin β6 expression.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov