Recruiting

Integrin αvβ6-targeted PET in Malignant Tumors

ClinicalTrials.gov IDNCT05835570

PhaseNot Applicable

Enrollment200

SponsorZhongnan Hospital

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Malignant Neoplasm, PET/CT, Non-Small Cell Lung Cancer, Breast Cancer, Metastatic

About this study

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.

Interventions

Diagnostic Test: PET/CT scans — Diagnostic 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.

Primary outcomes

The diagnostic sensitivity and specificity of 68Ga-Integrin αvβ6 PET/CT in the staging of malignant tumors (2 years)

Eligibility information

Inclusion Criteria: * 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; * Female subjects of reproductive age, male subjects and their partners agree to use reliable contraceptive measures (e.g., abstinence, birth control pills, injectable contraceptives, or subcutaneous contraceptive implants) until 6 months after the completion of the study; * Participants should voluntarily consent to the clinical trial, and have the ability to understand and sign an informed consent form. Exclusion Criteria: * Known allergy to injection or its excipients; * Severe liver or renal dysfunction; * Claustrophobia or other psychiatric disorders; * History of other malignant tumors; * Participation in another clinical trial within 30 days prior to PET/CT scan; * Pregnant or breastfeeding women; * Refusal to participate or request for withdrawing from the clinical study; * Other conditions deemed unsuitable for inclusion by investigator.

Study locations

Zhongnan Hospital of Wuhan University, Wuhan, Hubei 430071 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.