Targeting Integrin αvβ6 for PET Imaging in Cancer
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
Run by Zhongnan Hospital · NCT05835570 · Data updated 2026-11-12
This study is testing a new imaging tool to see if it can help doctors better diagnose and stage certain cancers, like lung and breast cancer, by using a special scan that targets a specific protein found in tumors.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Zhongnan Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | January 1, 2023 |
| Main results expected | November 30, 2025 |
| Study ends | December 30, 2025 |
| Registry record updated | April 30, 2025 |
| Trial ID | NCT05835570 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with newly diagnosed malignant tumors confirmed by pathology or suspected lung cancer.
✕Probably not a fit
Patients with severe liver or renal dysfunction, claustrophobia, or a history of other malignant tumors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on the use of a new PET imaging probe, 68Ga-Trivehexin, which targets integrin αvβ6, a protein specifically expressed in malignant tumors. The study aims to evaluate the diagnostic and staging capabilities of this probe in patients with newly diagnosed malignant tumors, including non-small cell lung cancer and breast cancer. Participants will undergo PET/CT scans to assess the probe's effectiveness compared to traditional imaging methods. The research seeks to improve early diagnosis and treatment evaluation for various cancers by providing a more precise imaging technique.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnosis and staging of malignant tumors, improving treatment outcomes for patients.
How similar studies have gone: While integrin-targeted imaging has been explored, this specific approach using integrin αvβ6 and the 68Ga-Trivehexin probe is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China Recruiting
Study contacts
- Principal investigator: Yong He, MD, PhD — Zhongnan Hospital
- Study coordinator: Yong He, MD, PhD
- Email: vincentheyong@163.com
- Phone: +86-27-67812698
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.