Targeting Integrin αvβ6 for PET Imaging in Cancer

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

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
• Enrollment: 200 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Zhongnan Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05835570 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed malignant tumors confirmed by pathology or suspected lung cancer.

Not a fit: Patients with severe liver or renal dysfunction, claustrophobia, or a history of other malignant tumors may not benefit from this study.

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 performed: 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.

Eligibility 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 this trial is running

Wuhan, Hubei

• 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

Conditions Malignant Neoplasm; PET/CT; Non-Small Cell Lung Cancer; Breast Cancer, Metastatic; Non-small cell lung cancer; Breast cancer; Integrin-αvβ6; [68Ga]Ga-Trivehexin