Actively Recruiting

Age: 18Years - 85Years
All Genders
ID05835570

Evaluation of Integrin b1vb26-targeted PET Imaging for Malignant Tumors in a Single-center Clinical Study

Led by Zhongnan Hospital · Updated on 2025-04-30

200

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating a new PET imaging method targeting integrin b1vb26, a molecule found almost exclusively in cancerous or reconstructed epithelial cells, to improve diagnosis and staging of malignant tumors. This approach aims to overcome limitations of the widely used 18F-FDG PET, which can produce false positives and negatives. Integrin b1vb26 is considered a promising biomarker due to its high specificity to tumor cells and minimal expression in healthy tissues. Participants diagnosed with malignant tumors or suspected lung cancer will undergo both 18F-FDG and 68Ga-Trivehexin PET/CT scans within one week. The new 68Ga-Trivehexin probe has shown favorable characteristics including high affinity for integrin b1vb26 and low background uptake in normal tissues except the kidneys. Its safety and metabolic stability have been supported by initial clinical data. The study will assess and compare the diagnostic performance of these imaging methods for detecting primary tumors, lymph node involvement, and metastases. During the study, participants will receive PET/CT imaging after injection of the 68Ga-Trivehexin tracer without special preparation. Researchers will evaluate diagnostic sensitivity and specificity over two years, comparing findings with standard 18F-FDG scans and correlating tracer uptake with tumor integrin expression. Participants must consent to the trial and will be monitored for any issues while the study follows their tumor status through imaging results and clinical assessments.

CONDITIONS

Brief Title

Integrin αvβ6-targeted PET in Malignant Tumors

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants with newly diagnosed malignant tumor confirmed by pathology or suspected lung cancer
  • Age 18 years or older, any gender
  • No prior anti-tumor therapy such as chemotherapy, radiotherapy, targeted therapy, or immunotherapy before PET/CT
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
  • Female participants of reproductive age and male participants and their partners agree to use reliable contraceptive measures until 6 months after the study
  • Ability to understand and voluntarily sign informed consent
Not Eligible

You will not qualify if you...

  • Known allergy to injection or its components
  • Severe liver or kidney dysfunction
  • Claustrophobia or psychiatric disorders
  • History of other malignant tumors
  • Participation in another clinical trial within 30 days before PET/CT scan
  • Pregnant or breastfeeding women
  • Refusal to participate or desire to withdraw from the study
  • Other conditions deemed unsuitable by the investigator

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within 1 week

Participants undergo PET/CT scans using 68Ga-Trivehexin and 18F-FDG to detect primary tumors, lymph nodes, and metastases.

2 visits (in-person) for PET/CT scans

Long-term Monitoring

Duration - Up to 2 years

Participants are monitored for diagnostic outcomes and correlation of imaging results with pathology over a period of up to 2 years.

Follow-up visits as needed for assessment

Trial Site Locations

Total: 1 location

1

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China, 430071

Actively Recruiting

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Research Team

Y

Yong He, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Comparison of the RGD Motif-Containing αvβ6 Integrin-Binding Peptides SFLAP3 and SFITGv6 for Diagnostic Application in HNSCC.

Saskia Roesch, Thomas Lindner, Max Sauter...

https://pubmed.ncbi.nlm.nih.gov/29674419

Preclinical Development and First-in-Human Imaging of the Integrin αvβ6 with [18F]αvβ6-Binding Peptide in Metastatic Carcinoma.

Sven H Hausner, Richard J Bold, Lina Y Cheuy...

https://pubmed.ncbi.nlm.nih.gov/30401687

A Microdose PET Study of the Safety, Immunogenicity, Biodistribution, and Radiation Dosimetry of 18F-FB-A20FMDV2 for Imaging the Integrin αvβ6.

Nicholas Keat, Julia Kenny, Keguan Chen...

https://pubmed.ncbi.nlm.nih.gov/29438002

Antibody-mediated blockade of integrin alpha v beta 6 inhibits tumor progression in vivo by a transforming growth factor-beta-regulated mechanism.

Louise A Koopman Van Aarsen, Diane R Leone, Steffan Ho...

https://pubmed.ncbi.nlm.nih.gov/18199553

A peptide selected by biopanning identifies the integrin alphavbeta6 as a prognostic biomarker for nonsmall cell lung cancer.

Anissa N Elayadi, Kausar N Samli, Ludmila Prudkin...

https://pubmed.ncbi.nlm.nih.gov/17575158

PET/CT imaging of head-and-neck and pancreatic cancer in humans by targeting the "Cancer Integrin" αvβ6 with Ga-68-Trivehexin.

Neil Gerard Quigley, Katja Steiger, Sebastian Hoberück...

https://pubmed.ncbi.nlm.nih.gov/34559266