RecruitingNCT05835570

Integrin αvβ6-targeted PET in Malignant Tumors

A Single-arm, Open-label, Single-center Clinical Study to the Evaluation of Integrin αvβ6-targeted Positron Emission Tomography (PET) for Malignant Tumors

Sponsor

Zhongnan Hospital

Enrollment

200 participants

Start Date

Jan 1, 2023

Study Type

OBSERVATIONAL

Conditions

PET/CT Malignant Neoplasm

Summary

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria6

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 Criteria8

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.

Interventions

DIAGNOSTIC_TESTPET/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.