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
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Zhongnan Hospital of Wuhan University | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Zhongnan Hospital |
China,
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
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 |
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