Integrin αvβ6-targeted PET in Malignant Tumors

April 27, 2025 updated by: Yong He, Zhongnan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Integrins are key members of the cell adhesion molecular family and play a central role in regulating cell-cell and cell-extracellular matrix interactions. They are highly expressed in a variety of malignant tumors and plays a vital role in the angiogenesis, invasion and metastasis of tumors, and the regulation of immune microenvironment. As such, integrins have emerged as potential targets for tumor-specific imaging. To date, PET tracers targeting integrin αvβ3 have been extensively studied for imaging tumor neovascularization. However, this integrin subtype also shows certain expression in normal tissue endothelial cells, posing a challenge to its clinical value as a specific marker for tumor imaging. In contrast, integrin αvβ6, another subtype of integrin known as "cancer integrin", is specifically expressed in epithelial-derived tumor cells, whereas it hardly expressed in human healthy tissues. Therefore, integrin αvβ6 has gained attention as an attractive and promising biomarker.

In the past decade, some integrin αvβ6-targeting PET tracers have been synthesized, but these agents have shown relatively low affinity and specificity, with high nonspecific uptake in the gastrointestinal tract, which hinders their clinical translation. Recently, Quigley et al. introduced a novel αvβ6-targeted trimeric probe based on a cyclic peptide c[YRGDLAYp(NMe)K], named 68Ga-Trivehexin. This probe demonstrated favorable characteristics, including excellent targeting affinity (IC50 = 0.047 nM), enhanced tumor uptake, and longer retention time in preclinical study. The preliminary results from PET imaging in 4 cancer patients further demonstrated intense 68Ga-Trivehexin accumulation in head and neck squamous cell carcinoma, parotid adenocarcinoma and pancreatic ductal adenocarcinoma; moreover, there was almost no physiological uptake in normal tissues and organs, such as stomach, intestine, liver, and lung, except for kidney (the excretory organ), resulting in an excellent tumor-to-background ratio.

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. This project is expected to provide a new and precise evaluation method for malignant tumors to compensate for the shortcomings of current imaging methods.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Recruiting
        • Zhongnan Hospital Of Wuhan University
        • Contact:
          • Lei Zheng
          • Phone Number: +86-27-67812787
        • Principal Investigator:
          • Yong He, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

in-patinets

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic sensitivity and specificity of 68Ga-Integrin αvβ6 PET/CT in the staging of malignant tumors
Time Frame: 2 years
The diagnostic performance of [68Ga]Ga-Trivehexin PET/CT and [18F]-FDG PET/CT for initial staging will be evaluated and compared using histopathological findings or typical imaging features as reference standard.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of primary and metastatic lesions between [68Ga]Ga-Trivehexin PET/CT and [18F]FDG PET/CT
Time Frame: 2 years
  1. Comparison of tracer uptake values of primary and metastatic lesions between [68Ga]Ga-Trivehexin PET/CT and [18F]FDG PET/CT.
  2. Evaluation of the correlation between [68Ga]Ga-Trivehexin-derived parameters and tumor integrin β6 expression.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongnan Hospital

Investigators

  • Principal Investigator: Yong He, MD, PhD, Zhongnan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 27, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZNYYHYXK0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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