Clinical Evaluation of a 68Ga-Labeled B7-H3 Nanobody for ImmunoPET Imaging in Patients With Osteosarcoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Lesion detection rate of 68Ga-B7-H3 nanobody PET/CT
研究概览
简要总结
This study aims to evaluate the safety, feasibility, and imaging performance of a novel 68Ga-labeled B7-H3 nanobody for immunoPET imaging in patients with osteosarcoma. Participants with suspected or histologically confirmed osteosarcoma will undergo 68Ga-B7-H3 nanobody PET/CT imaging according to the study protocol. Imaging findings will be compared with conventional imaging and, when available, histopathological results. The study will assess tracer biodistribution, tumor uptake, lesion detectability, and safety to determine the potential clinical value of B7-H3-targeted immunoPET for the diagnosis and evaluation of osteosarcoma.
详细描述
B7-H3 (CD276) is an immune checkpoint molecule that is highly expressed in a variety of malignant tumors, including osteosarcoma, while showing limited expression in most normal tissues. Because of its high tumor-associated expression, B7-H3 has emerged as a promising molecular imaging and therapeutic target.
This is a prospective, single-center clinical study designed to evaluate a novel 68Ga-labeled B7-H3 nanobody as an immunoPET imaging agent in patients with osteosarcoma. Eligible participants will receive an intravenous administration of the investigational radiotracer followed by PET/CT imaging at the prespecified imaging time point(s). Safety assessments will include monitoring of adverse events and other clinically relevant evaluations as specified in the protocol.
Imaging findings will be analyzed to characterize tracer biodistribution and tumor uptake and will be compared with standard imaging examinations and histopathological findings whenever available. The study is intended to investigate the feasibility and diagnostic performance of 68Ga-B7-H3 nanobody immunoPET for the detection and evaluation of osteosarcoma and to provide clinical evidence supporting the further development of B7-H3-targeted molecular imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥10 years.
- •Histologically confirmed osteosarcoma.
- •Relapsed or refractory disease following failure of first- or second-line systemic therapy.
- •Ability to understand the study procedures and provide written informed consent (or assent with parental/legal guardian consent, where applicable).
排除标准
- •Pregnant or breastfeeding.
- •Severe uncontrolled systemic disease or medical condition that, in the investigator's judgment, may interfere with study participation or image interpretation.
- •Unable to undergo PET/CT examination.
- •Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
结局指标
主要结局
Lesion detection rate of 68Ga-B7-H3 nanobody PET/CT
时间窗: Baseline (at the time of PET/CT imaging)
Number and proportion of osteosarcoma lesions detected by 68Ga-B7-H3 nanobody PET/CT, using histopathology and/or clinical follow-up as the reference standard.
Number of participants with 68Ga-PFBH01-related adverse events
时间窗: 30 ± 3 days
Number and proportion of participants experiencing one or more adverse events considered related to 68Ga-PFBH01 administration. Adverse events will be recorded from tracer administration through 30 ± 3 days after PET/CT and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
次要结局
- Maximum standardized uptake value (SUVmax) of 68Ga-PFBH01 in osteosarcoma lesions(At the time of PET/CT imaging ("Baseline"))