试验雷达 AI | ||
|---|---|---|
临床试验 NCT05835570 针对恶性肿瘤，PET-CT，非小细胞肺癌，乳腺癌转移目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
一个试验符合筛选条件
卡片视图
Integrin αvβ6-targeted PET in Malignant Tumors 200
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT05835570是一项针对恶性肿瘤，PET-CT，非小细胞肺癌，乳腺癌转移的观察研究试验，目前试验状态为招募中。试验始于2023年1月1日，计划招募200名患者。该研究由Zhongnan Hospital主导，预计于2025年12月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年4月30日。
简要概括
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...显示更多
详细描述
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...显示更多
官方标题
A Single-arm, Open-label, Single-center Clinical Study to the Evaluation of Integrin αvβ6-targeted Positron Emission Tomography (PET) for Malignant Tumors
疾病
恶性肿瘤PET-CT非小细胞肺癌乳腺癌转移出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- ZNYYHYXK0003
NCT编号
实际开始日期
2023-01-01
最近更新发布
2025-04-30
预计完成日期
2025-12-30
计划入组人数
200
研究类型
观察研究
试验状态
招募中
关键词
Non-small cell lung cancer
Breast cancer
Integrin-αvβ6
[68Ga]Ga-Trivehexin
Malignant tumors
Breast cancer
Integrin-αvβ6
[68Ga]Ga-Trivehexin
Malignant tumors
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
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...显示更多 | 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. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
The diagnostic sensitivity and specificity of 68Ga-Integrin αvβ6 PET/CT in the staging of malignant tumors | 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 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Comparison of primary and metastatic lesions between [68Ga]Ga-Trivehexin PET/CT and [18F]FDG PET/CT | 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 |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- 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.
- 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.
Zhongnan Hospital研究责任方
Yong He, 主要研究者, Chief of Department of Nuclear Medicine, Zhongnan Hospital
研究中心联系人
联系人: Yong He, MD, PhD, +86-27-67812698, [email protected]
1 位于 1 个国家/地区的研究中心
Hubei
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071, China
Lei Zheng, 联系人, +86-27-67812787
Yong He, MD, PhD, 主要研究者
招募中