The Clinical Application Value of SPECT Imaging Targeting LRRC15 in Malignant Tumors
Here's a polished version of the text:
"This project involves patients with high-expression LRRC15 malignant tumors who are either clinically suspected of or diagnosed with pancreatic cancer, breast cancer, lung cancer, ovarian cancer, head and neck tumors, colorectal cancer, melanoma, etc., as well as healthy volunteers. Using a targeted LRRC15-specific SPECT imaging agent, SPECT/CT imaging is performed to achieve the following objectives:
For malignant tumor patients:
To support disease diagnosis and staging. Diagnostic performance will be evaluated against the gold standard of pathological diagnosis, clarifying the presence or absence of lesions and determining their location and nature.
To enable accurate staging and assess tumor burden by comparison with [18F]FDG PET/CT, thereby aiding in the determination of treatment plans.
For healthy volunteers:
To conduct pharmacokinetic analysis, elucidating the distribution, metabolism, and safety profile of the agent in the body."
研究概览
地位
研究类型
注册 (实际的)
联系人和位置
学习地点
-
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Hubei
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Wuhan、Hubei、中国、430030
- Wuhan Union Hospital, China
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
Each subject must meet all of the following inclusion criteria to be eligible for study enrollment:
- The subject or their legally authorized representative (LAR) is capable of providing a signed and dated informed consent form (ICF);
- Willing and able to comply with all study procedures and cooperate throughout the entire duration of the study;
- Adult patients or healthy volunteers, aged 18 years or older, male or female;
- Patients with clinically suspected or confirmed malignancies (supported by evidence such as relevant serum tumor markers, imaging modalities including ultrasound, CT, and MRI, or histopathological examinations) who are in good general condition;
- Women of childbearing potential (WOCBP) must have used effective contraception for at least one month prior to screening and agree to continue contraceptive use throughout the study period and for a specified duration following study completion;
- Must meet any other protocol-specified inclusion criteria.
Exclusion Criteria:
Any subject meeting any of the following baseline criteria will be excluded from the study:
- Inability to tolerate or complete SPECT/CT examinations (including, but not limited to, the inability to lie supine, claustrophobia, radiophobia, etc.);
- Presence of other comorbidities, such as acute systemic illnesses and electrolyte imbalances;
- Known allergy or hypersensitivity to the LRRC15 radiotracer or its synthetic excipients; fasting blood glucose level exceeding 11.0 mmol/L prior to [¹⁸F]FDG injection;
- Patients deemed by the investigator to have poor expected compliance;
- Pregnant or lactating (nursing) women;
- Presence of any other conditions or factors that, in the opinion of the investigator, would make the subject unsuitable for participation in this trial.
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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病灶和生物分布的视觉及标准化摄取值评估
大体时间:1年
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至少两名经验丰富的核医学医师将通过共识阅读进行视觉分析。在每例病例的半定量分析后,测量肿瘤和器官的标准摄取值(SUV)。SUV范围为0到无穷大,分数越高表示肿瘤对靶向LRRC15核探针的摄取越高,这暗示着肿瘤为恶性的风险越大或分期越高。
|
1年
|
合作者和调查者
调查人员
- 研究主任:Xiaoli Lan, PhD、Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
- 泌尿生殖系统疾病
- 生殖器疾病
- 内分泌系统疾病
- 泌尿生殖系统肿瘤
- 按部位分类的肿瘤
- 肿瘤
- 女性泌尿生殖系统疾病
- 女性泌尿生殖系统疾病和妊娠并发症
- 肠道疾病
- 呼吸道疾病
- 组织学类型的肿瘤
- 消化道肿瘤
- 消化系统肿瘤
- 消化系统疾病
- 肠胃疾病
- 肠道肿瘤
- 直肠疾病
- 生殖器疾病,女性
- 肺部疾病
- 内分泌腺肿瘤
- 胰腺疾病
- 肿瘤、腺体和上皮
- 呼吸道肿瘤
- 胸部肿瘤
- 结肠疾病
- 卵巢疾病
- 附件疾病
- 生殖器肿瘤,女性
- 性腺疾病
- 皮肤病
- 乳腺疾病
- 星形细胞瘤
- 胶质瘤
- 肿瘤,神经上皮
- 神经外胚层肿瘤
- 肿瘤、生殖细胞和胚胎
- 肿瘤,神经组织
- 神经内分泌肿瘤
- 肿瘤、结缔组织和软组织
- 痣和黑色素瘤
- 皮肤肿瘤
- 皮肤和结缔组织疾病
- 肺肿瘤
- 结直肠肿瘤
- 卵巢肿瘤
- 乳腺肿瘤
- 胰腺肿瘤
- 胶质母细胞瘤
- 头颈肿瘤
- 黑色素瘤
- 肉瘤
其他研究编号
- XLan-250202
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