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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
Contact Information
Primary
Yong He, MD, PhD
vincentheyong@163.com
+86-27-67812698
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 200
Treatments
Integrin αvβ6-targeted PET in malignant tumors
Participants: newly diagnosed malignant tumor confirmed by pathology or suspected lung cancer. Interventions: Participant who conforms to the inclusion criteria will undergo 18F-FDG and 68Ga-Trivehexin PET/CT scans within 1 week.~Interventions: Participant who conforms to the inclusion criteria will undergo 18F-FDG and 68Ga-Trivehexin PET/CT scans within 1 week.~Objectives: This study aims to assess and compare the diagnostic performance of 68Ga-Trivehexin and 18F-FDG PET/CT for the detection of primary tumors, mediastinal lymph nodes and distant metastases, and to explore the correlation between 68Ga-Trivehexin accumulation and immunohistochemical β6 expression in NSCLC.
Sponsors
Leads: Zhongnan Hospital

This content was sourced from clinicaltrials.gov