Integrin αvβ6-targeted PET in Malignant Tumors

Trial Title: Integrin αvβ6-targeted PET in Malignant Tumors

NCT ID: NCT05835570

Condition: Malignant Neoplasm
PET/CT
Integrin αvβ6

Conditions: Official terms:
Neoplasms

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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 and compare it to 18F-FDG, providing a new and precise evaluation method for malignant tumors.

Detailed description: Malignant tumors are a significant disease that threatens human health and life, with high incidence and mortality rates. Molecular imaging plays an important role in the early diagnosis, staging, prognosis evaluation, and therapeutic efficacy assessment of major diseases such as tumors. Currently, 18F-FDG PET imaging is the most widely used molecular imaging, but there are still problems such as physiological uptake, false negatives, and false positives. It is urgent to explore and develop a new type of tumor-targeting PET imaging. Integrin αvβ6 can only be expressed in epithelial cells that undergo a cancerous transformation or tissue reconstruction and is almost not expressed in healthy epithelial cells, with better expression specificity, hence αvβ6 is also known as "cancer integrin". Recently, a new PET probe targeting integrin αvβ6, 68Ga-Trivehexin, has been successfully developed internationally in 2021, with significantly better tumor affinity and selectivity than other similar probes, and can effectively distinguish malignant tumors from inflammatory lesions. The safety and metabolic stability of 68Ga-Trivehexin targeting integrin αvβ6 are currently supported by clinical data, and this project will further expand its application in various malignant tumors, clarify its diagnostic and staging value in different types of tumors, and qualitative and quantitative characteristics, and compare it head-to-head with 18F-FDG. This project is expected to provide a new and precise evaluation method for malignant tumors to compensate for the shortcomings of current imaging methods.

Criteria for eligibility:

Study pop:
in-patinets

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Volunteering to participate in clinical trials and sign an informed consent form Patients with suspected or confirmed malignant tumor Exclusion Criteria: - Female patients plan to become pregnant within 6 months Pregnant and lactating women Patients are allergic to multiple drugs including test drugs Patients have participated in other clinical trials in the past month.

Gender: All

Minimum age: 18 Years

Maximum age: 85 Years

Healthy volunteers: No

Locations:

Facility:
Name: Zhongnan Hospital of Wuhan University

Address:
City: Wuhan
Zip: 430071
Country: China

Status: Recruiting

Contact:
Last name: Lei Zheng

Phone: +86-27-67812787

Investigator:
Last name: Yong He, MD, PhD
Email: Principal Investigator

Start date: January 1, 2023

Completion date: December 13, 2024

Lead sponsor:
Agency: Zhongnan Hospital
Agency class: Other

Source: Zhongnan Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05835570