Integrin αvβ6-targeted PET in Malignant Tumors

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05835570
• Other study ID #: ZNYYHYXK0003
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 13, 2024

Study information

• Verified date: December 2022
• Source: Zhongnan Hospital
• Contact: Yong He, MD, PhD
• Phone: +86-27-67812698
• Email: vincentheyong[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 13, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms
• PET/CT

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Quigley NG, Steiger K, Hoberuck S, Czech N, Zierke MA, Kossatz S, Pretze M, Richter F, Weichert W, Pox C, Kotzerke J, Notni J. PET/CT imaging of head-and-neck and pancreatic cancer in humans by targeting the "Cancer Integrin" alphavbeta6 with Ga-68-Trivehexin. Eur J Nucl Med Mol Imaging. 2022 Mar;49(4):1136-1147. doi: 10.1007/s00259-021-05559-x. Epub 2021 Sep 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic sensitivity and specificity of 68Ga-Integrin avß6 PET/CT in the staging of malignant tumors	Taking the pathology or clinical follow-up as gold standard, the sensitivity and specificity of 68Ga-Integrin avß6 PET/CT in detecting malignant tumor were calculated.	2 years